FDA Orange Book · active-ingredient family
Ampicillin sodium
Ampicillin sodium: 2 brands, 29 generics; first approved Apr 04, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 29 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
29
Listed patents
0
Presentations
109
Brand (NDA) products
Originator applications
- PENBRITIN-SRLDWYETH AYERSTNDA 050072—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — - BRISTOLNDA 050309—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (29)
Abbreviated applications
- AMPICILLIN SODIUMSAGENT PHARMS INCANDA 09058320155 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMSAGENT PHARMS INCANDA 0905812015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMHOSPIRAANDA 20286420154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMHOSPIRAANDA 2028652015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMONESOURCE SPECIALTYANDA 20102520144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMONESOURCE SPECIALTYANDA 2021982014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMISTITUTO BIO ITA SPAANDA 2014042013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMACS DOBFAR SPAANDA 09088420133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMACS DOBFAR SPAANDA 0908892013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMEUGIA PHARMA SPECLTSANDA 06549920105 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMEUGIA PHARMA SPECLTSANDA 0654932010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMANTIBIOTICEANDA 09035420094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMISTITUTO BIO ITA SPAANDA 06279719932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMHQ SPECLT PHARMAANDA 06277219938 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMHQ SPECLT PHARMAANDA 0631421993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMWATSON LABS INCANDA 06281619885 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMWATSON LABS INCANDA 0629941988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMAPOTHECONANDA 06286019885 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMISTITUTO BIO ITA SPAANDA 06271919873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - AMPICILLIN SODIUMSANDOZANDA 06273819872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL POWDER INTRAVENOUS Discontinued — EQ 2GM BASE/VIAL POWDER INTRAVENOUS Discontinued — - AMPICILLIN SODIUMINTL MEDICATIONANDA 06263419872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 06272719862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - WYETH AYERSTANDA 06271819865 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMHIKMAANDA 06269219866 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMLILLYANDA 06256519853 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMCONSOLIDATED PHARMANDA 061936—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - AMPICILLIN SODIUMRSSANDOZANDA 061395—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - WYETH AYERSTANDA 060626—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 060677—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
42 yr ago
Most recent approval
10 yr 11 mo ago
Approvals span 1985–2015 across 31 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 2994%
Ampicillin sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
