FDA Orange Book · active-ingredient family
Cephalothin sodium
Cephalothin sodium: 1 brand, 9 generics; first approved Nov 15, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- LILLYNDA 050482—4 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 — EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 20GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- CEPHALOTHIN SODIUMABRAXIS PHARMANDA 06266619872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 06273019872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — - CEPHALOTHIN SODIUMABBOTTANDA 06254719852 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 — - CEPHALOTHIN SODIUMABBOTTANDA 06254819852 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 — - LILLYANDA 06254919852 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 — - INTL MEDICATIONANDA 06242619854 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 — - CEPHALOTHIN SODIUMBRISTOLANDA 06246419843 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 — EQ 4GM BASE/VIAL INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 06242219846 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 20MG BASE/ML INJECTABLE INJECTION Discontinued — EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 06243519833 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 — 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
43 yr 5 mo ago
Most recent approval
35 yr 7 mo ago
Approvals span 1983–1991 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Cephalothin 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.
