Drug

Who makes albuterol sulfate?

40 companies list albuterol sulfate as a human prescription drug, including under the names ProAir Digihaler, ProAir RespiClick, VENTOLIN HFA. Forms: aerosol, metered; inhalant; powder, metered; solution; syrup; tablet. Routes: oral, respiratory (inhalation).

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing albuterol sulfate

CompanyFormsApplicationNDCsRegistered sites
NuCare Pharmaceuticals,Inc.United Statesaerosol, metered; inhalant; solutionANDA, NDA, NDA AUTHORIZED GENERICANDA074880, ANDA077839, ANDA207085101
International Medication Systems, Ltd.United Statesaerosol, metered; inhalant; solutionANDA, NDA, NDA AUTHORIZED GENERICANDA074880, ANDA077839, ANDA20995483
Preferred Pharmaceuticals Inc.United Statesaerosol, metered; inhalant; solution; syrupANDA, NDA AUTHORIZED GENERICANDA077839, ANDA207085, ANDA20785781
Proficient Rx LPUnited Statesaerosol, metered; solutionANDA, NDA, NDA AUTHORIZED GENERICANDA074880, ANDA203760, ANDA20708581
RemedyRepack, IncUnited Statesaerosol, metered; inhalant; solutionANDA, NDA, NDA AUTHORIZED GENERICANDA206224, ANDA207857, ANDA20995481
Chartwell RX, LLC.solution; syrup; tabletANDAANDA072151, ANDA074880, ANDA07566470
ASCLEMED USA INC. DBA ENOVACHEMUnited Statesaerosol, metered; solutionANDA, NDAANDA074880, ANDA207085, ANDA20995451
Rising Pharma Holdings, Inc.United StatessolutionANDAANDA074880, ANDA075664, ANDA07635541
The Ritedose CorporationUnited StatessolutionANDAANDA077839, ANDA214531, ANDA21838641
Nephron Pharmaceuticals CorporationsolutionANDAANDA074880, ANDA075664, ANDA07635540
Sportpharm LLCaerosol, metered; solutionANDAANDA074880, ANDA203760, ANDA20708540
Sun Pharmaceutical Industries LimitedIndiasolution; tabletANDAANDA072637, ANDA207857313
Aurobindo Pharma LimitedIndiasolutionANDAANDA206224, ANDA21188836
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited Statesinhalant; solution; tabletANDAANDA072637, ANDA077839, ANDA20995935
HF Acquisition Co LLCUnited Statesaerosol, metered; solutionANDA, NDAANDA074880, ANDA203760, NDA02098331
Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.ChinasolutionANDAANDA206224, ANDA21188831
Cardinal Health 418, Inc.United StatessolutionANDAANDA077839234
CIPLA PHARMACEUTICALS LIMITEDIndiaaerosol, metered; inhalantANDAANDA209959, ANDA21940927
Nivagen Pharmaceuticals LLCUnited StatestabletANDAANDA21094822
Bryant Ranch PrepackUnited StatessyrupANDAANDA21219721
Golden State Medical Supply Inc.United StatestabletANDAANDA07263721
Ingenus Pharmaceuticals, LLCsolutionANDAANDA21557120
Teva Respiratory, LLCinhalant; powder, meteredNDANDA20563620
GlaxoSmithKline Biologicals SAUnited Kingdomaerosol, meteredNDANDA020983119
Lupin LimitedIndiaaerosol, meteredANDAANDA209954114
Teva Pharmaceutical Industries Ltd.Canadaaerosol, meteredNDA AUTHORIZED GENERICNDA02145716
Sandoz Industrial Products S.AAustriaaerosol, meteredNDA AUTHORIZED GENERICNDA02050315
Hikma Pharmaceuticals USA Inc.United Statesaerosol, meteredANDAANDA20708514
Padagis Israel Pharmaceuticals LtdUnited Statesaerosol, meteredANDAANDA20376012
QUAGEN PHARMACEUTICALS LLCUnited StatessyrupANDAANDA21219712
ADVANCED RX PHARMACY OF TENNESSEE LLCUnited Statesaerosol, meteredANDAANDA20995411
Armstrong Pharmaceuticals, Inc.United StatesinhalantANDAANDA21244711
HAWAII REPACK INCUnited Statesaerosol, meteredANDAANDA20708511
Medical Purchasing Solutions, LLCUnited StatessolutionANDAANDA07783911
Advanced Rx of Tennessee, LLCaerosol, meteredNDA AUTHORIZED GENERICNDA02098310
Amneal Pharmaceuticals NY LLCinhalantANDAANDA21160010
Chartwell Governmental & Specialty RX, LLC.syrupANDAANDA07778810
Exelan Pharmaceuticals, Inc.inhalantANDAANDA20995910
Mylan Pharmaceuticals, Inc.solutionANDAANDA07783910
Prasco Laboratoriesaerosol, meteredNDA AUTHORIZED GENERICNDA02098310

Bulk ingredient listings

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Common questions

Who makes albuterol sulfate?
40 companies list albuterol sulfate as a human prescription drug in the openFDA NDC Directory, led by NuCare Pharmaceuticals,Inc., International Medication Systems, Ltd., Preferred Pharmaceuticals Inc., Proficient Rx LP, RemedyRepack, Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic ProAir Digihaler?
34 companies list albuterol sulfate under an abbreviated new drug application (ANDA), the application type used for generics, and 8 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies albuterol sulfate active ingredient?
12 companies list albuterol sulfate as a bulk ingredient, including Lusochimica SPA, Melody Healthcare Pvt Ltd, Professional Compounding Centers of America dba PCCA, CAMBREX PROFARMACO MILANO SRL.