Meperidine Hydrochloride

Manages acute pain severe enough to require an opioid analgesic. ANDA 40893, held by Genus. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 40893 (Meperidine Hydrochloride), held by Genus, was first approved by FDA on Jun 24, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 24, 2009
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meperidine hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including meperidine hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Meperidine hydrochloride tablets should not be used for treatment of chronic pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 24, 2009	Original application	Approved	REMS

Products

4 strengths and forms


Meperidine Hydrochloride50MG · tablet;oral	Meperidine Hydrochloride	Rx
Meperidine Hydrochloride75MG · tablet;oral	Meperidine Hydrochloride	Discontinued
Meperidine Hydrochloride100MG · tablet;oral	Meperidine Hydrochloride	Discontinued
Meperidine Hydrochloride150MG · tablet;oral	Meperidine Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 9REMS	Approved	None posted
Dec 22, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 7REMS	Approved	None posted
Dec 15, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 4REMS	Approved	None posted
Jun 24, 2009	Original application	Approved	REMS

Identifiers

Application: ANDA 40893
Drugs@FDA: Overview at FDA
Company: Genus Lifesciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters