Is Accupril still available?

Accupril (NDA 019885) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Accupril have a generic?

Yes. The Orange Book lists 13 approved generic (ANDA) applications sharing Accupril's active ingredient (Quinapril Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Accupril's FDA application number?

Accupril is approved under NDA 019885, held by Pfizer Pharms.

Orange Book product · Brand (NDA)

Accupril

Quinapril Hydrochloride

Brand (NDA)NDA 019885DiscontinuedRLD Pfizer Pharms

Approved

Nov 19, 1991

Application

Brand (NDA)

TE code

Not listed

Listed patents

Accupril (Quinapril Hydrochloride) is Pfizer Pharms's brand-name drug, approved by the FDA under NDA 019885 in 1991. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 13 approved generics share this drug's active ingredient.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.
Nov 19, 1991
35 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

QUINAPRIL HYDROCHLORIDE

Strength

EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 019885

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 019885

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 Quinapril Hydrochloride 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.

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

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