Is Acetaminophen still available?

Yes. Acetaminophen (NDA 204957) is listed with marketing status Prescription in the FDA Orange Book.

Does Acetaminophen have a generic?

Yes. The Orange Book lists 29 approved generic (ANDA) applications sharing Acetaminophen's active ingredient (Acetaminophen). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Acetaminophen's TE code AP2 mean?

AP2 is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Acetaminophen substitutable for its reference brand with no expected difference in clinical effect.

What is Acetaminophen's FDA application number?

Acetaminophen is approved under NDA 204957, held by B Braun Medical.

Orange Book product · Brand (NDA)

Acetaminophen

Brand (NDA)NDA 204957TE AP2RLD B Braun Medical

Approved

Feb 18, 2021

Application

Brand (NDA)

TE code

AP2

Listed patents

Acetaminophen (Acetaminophen) is B Braun Medical's brand-name drug, approved by the FDA under NDA 204957 in 2021. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AP2, so the FDA considers it substitutable for the reference brand. 29 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Feb 18, 2021
5 yr 6 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN

Strength

1GM/100ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP2

Application

NDA 204957

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 204957

500MG/50ML (10MG/ML)SOLUTION

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Acetaminophen 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.

Acetaminophen — 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 Acetaminophen active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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