Home NDC 50383-740 Albuterol Sulfate
Product NDC 50383-740
11-digit product format 503830740
Labeler code 50383
Product ID 50383-740_8286f8f0-8267-4502-adf0-c15d47d6ad7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Albuterol Sulfate
Dosage form SYRUP
Route ORAL
Labeler Akorn
Application ANDA074749
Marketing category ANDA
Marketing start 1998-01-30
Marketing end 0000-00-00
Substance ALBUTEROL SULFATE
Active strength 2 mg/5mL
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 A074749-001 ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 1998-01-30
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 A074749-001 ALBUTEROL SULFATE EQ 2MG BASE/5ML SYRUP / ORAL 1998-01-30 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-740-16 Albuterol Sulfate 473 mL in 1 BOTTLE SYRUP 473 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 SACCHARIN INACTIVE INGREDIENT FST467XS7D ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 SACCHARIN INACTIVE INGREDIENT FST467XS7D ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 SACCHARIN INACTIVE INGREDIENT FST467XS7D ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 SACCHARIN INACTIVE INGREDIENT FST467XS7D ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SYRUP [PREFERRED PHARMACEUTICALS, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.] 2 ALBUTEROL SULFATE ACTIVE INGREDIENT 021SEF3731 ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 ALBUTEROL ACTIVE MOIETY QF8SVZ843E ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 SACCHARIN INACTIVE INGREDIENT FST467XS7D ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-740 ALBUTEROL SULFATE SYRUP [AKORN] 6 Legacy NDC, 1 package rows 20221103_d3544356-e36a-4ce6-8235-cb0531c658ad.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-740-16 50383074016 473 mL in 1 BOTTLE (50383-740-16) 473 ml 1998-01-30 0000-00-00 No No Current