Labeler · US market

Amphastar Pharmaceuticals, Inc.

Amphastar Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 12 drug concepts (12 currently active) across 26 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0548

Active drugs12

Registrations24 active / 24

Packages26

Sole supplier of2 drugs

Portfolio12 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Enoxaparin Sodium injection	rx	7	7	SUPPLYING
Medroxyprogesterone Acetate injection, suspension, extended release	rx	4	6	SUPPLYING
Neostigmine Methylsulfate injection	rx	2	2	SUPPLYING
Isoproterenol Hydrochloride injection, solution	rx	2	2	SUPPLYING
Glucagon powder	rx	2	2	SUPPLYING
Enoxaparin Sodium injection	rx	1	1	SUPPLYING
Vasopressin injection	rx	1	1	SUPPLYING
Glucagon kit	rx	1	1	SUPPLYING
Cosyntropin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Teriparatide injection	rx	1	1	SUPPLYING
Ganirelix Acetate injection	rx	1	1	SUPPLYING
Hyaluronidase injection	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes0548
Filing names1
Drugs (active)12
Drugs (all time)12
US registrations24
Packages26

Recent events

Shortages, recalls, and registration changes across all filing names.

Jan 13, 2022
SHORTAGEDrug shortage: Dextrose Monohydrate 50% Injection (Amphastar Pharmaceuticals, Inc.)
Jan 1, 2020
SHORTAGEDrug shortage: Atropine Sulfate Injection (Amphastar Pharmaceuticals, Inc.)
Dec 6, 2018
SHORTAGEDrug shortage: Morphine Sulfate Injection (Amphastar Pharmaceuticals, Inc.)
May 3, 2018
SHORTAGEDrug shortage: Lorazepam Injection (Amphastar Pharmaceuticals, Inc.)
Aug 15, 2017
RECALLRecall (Class II): Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals,…
Mar 1, 2017
SHORTAGEDrug shortage: Sodium Bicarbonate Injection (Amphastar Pharmaceuticals, Inc.)
Feb 22, 2012
SHORTAGEDrug shortage: Lidocaine Hydrochloride Injection (Amphastar Pharmaceuticals, Inc.)

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.