FDA Orange Book · active-ingredient family
Nafcillin sodium
Nafcillin sodium: 5 brands, 18 generics; first approved Aug 02, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
18
Listed patents
0
Presentations
52
Brand (NDA) products
Originator applications
- BAXTER HLTHCARENDA 05065519892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued - EQ 2GM BASE/100ML INJECTABLE INJECTION Rx - - UNIPENRLDWYETH AYERSTNDA 050320-6 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 - EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 20GM BASE/VIAL INJECTABLE INJECTION Discontinued - - WYETH AYERSTNDA 050111-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE CAPSULE ORAL Discontinued - - WYETH AYERSTNDA 050199-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SOLUTION ORAL Discontinued - - WYETH AYERSTNDA 050462-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued -
Generic (ANDA) products (18)
Abbreviated applications
- NAFCILLIN SODIUMFRESENIUSANDA 2067612020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued - - NAFCILLIN SODIUMFRESENIUSANDA 20668220192 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 - - NAFCILLIN SODIUMONESOURCE SPECIALTYANDA 20000220142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMRSEUGIA PHARMA SPECLTSANDA 09161320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMRSEUGIA PHARMA SPECLTSANDA 0916142012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMSAGENT PHARMSANDA 09058220122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMSAGENT PHARMSANDA 0905802012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMANTIBIOTICEANDA 09056020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMISTITUTO BIO ITA SPAANDA 09000220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMISTITUTO BIO ITA SPAANDA 0900052011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - NAFCILLIN SODIUMWATSON LABS INCANDA 06284419885 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 1.5GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued - - NAFCILLIN SODIUMWATSON LABS INCANDA 0630081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued - - NAFCILLIN SODIUMSANDOZANDA 06273219862 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 06275519862 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 06271719863 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 - - NAFCILLIN SODIUMSANDOZANDA 06252719844 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 - EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued - - NAFCILLIN SODIUMAPOTHECONANDA 061984-4 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 - EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GLAXOSMITHKLINEANDA 061999-4 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 - 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 10 mo ago
Most recent approval
6 yr 6 mo ago
Approvals span 1984–2020 across 23 FDA applications.
Brand (NDA) 522%
Generic (ANDA) 1878%
Nafcillin 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.
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