Is Anexsia 5/325 still available?

Yes. Anexsia 5/325 (ANDA 040409) is listed with marketing status Prescription in the FDA Orange Book.

What is Anexsia 5/325 a generic of?

Anexsia 5/325 is a generic (ANDA 040409) containing Acetaminophen; Hydrocodone Bitartrate. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Anexsia 5/325's TE code AA mean?

AA is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Anexsia 5/325 substitutable for its reference brand with no expected difference in clinical effect.

What is Anexsia 5/325's FDA application number?

Anexsia 5/325 is approved under ANDA 040409, held by Specgx LLC.

Orange Book product · Generic (ANDA)

Anexsia 5/325

Acetaminophen; Hydrocodone Bitartrate

Generic (ANDA)ANDA 040409TE AA Specgx LLC

Approved

Oct 20, 2000

Application

Generic (ANDA)

TE code

Listed patents

Anexsia 5/325 (Acetaminophen; Hydrocodone Bitartrate) is a generic drug approved under an ANDA (040409) in 2000, marketed by Specgx LLC. Its therapeutic-equivalence code is AA, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 20, 2000
26 yr 1 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Strength

325MG;5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 040409

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

Generic (ANDA) of Acetaminophen; Hydrocodone Bitartrate

View full Acetaminophen; Hydrocodone Bitartrate 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.

Anexsia 5/325 — 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; Hydrocodone Bitartrate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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