Home NDC 50383-741 Albuterol Sulfate
Product NDC 50383-741
11-digit product format 503830741
Labeler code 50383
Product ID 50383-741_8dcd2429-1d74-4612-8dac-9df6bc3a807c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Akorn
Application ANDA074543
Marketing category ANDA
Marketing start 1998-01-15
Marketing end 0000-00-00
Substance ALBUTEROL SULFATE
Active strength 5 mg/mL
Pharmacologic classes Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074543-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 1998-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074543-001 AN
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074543-001 ALBUTEROL SULFATE EQ 0.5% BASE SOLUTION / INHALATION AN 1998-01-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A074543-001 AN 1 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 3 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.] 1 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.] 1 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-741 ALBUTEROL SULFATE SOLUTION [AKORN] 8 Legacy NDC 20220302_34b6ab14-9ed5-4651-9be6-84685e6aa919.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50383-741-20 50383074120 1 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS 1998-01-15 0000-00-00 No No Current