Is Ampicillin Sodium still available?

Yes. Ampicillin Sodium (ANDA 061395) is listed with marketing status Prescription in the FDA Orange Book.

What is Ampicillin Sodium a generic of?

Ampicillin Sodium is a generic (ANDA 061395) containing Ampicillin Sodium. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Ampicillin Sodium's TE code AP mean?

AP is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Ampicillin Sodium substitutable for its reference brand with no expected difference in clinical effect.

What is Ampicillin Sodium's FDA application number?

Ampicillin Sodium is approved under ANDA 061395, held by Sandoz.

Orange Book product · Generic (ANDA)

Ampicillin Sodium

Generic (ANDA)ANDA 061395TE AP Sandoz

Approved

Approved Prior to Jan 1, 1982

Application

Generic (ANDA)

TE code

Listed patents

Ampicillin Sodium (Ampicillin Sodium) is a generic drug approved under an ANDA (061395), marketed by Sandoz. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

AMPICILLIN SODIUM

Strength

EQ 1GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Application

ANDA 061395

Product number

004

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 061395

Brand + generics

Active-ingredient family

Generic (ANDA) of Ampicillin Sodium

View full Ampicillin Sodium family

Orange Book patent file

Listed patents

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.

Ampicillin Sodium — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Ampicillin Sodium active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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