Home NDC 50383-043 Hydrocodone Bitartrate and Homatropine Methylbromide
Product NDC 50383-043
11-digit product format 503830043
Labeler code 50383
Product ID 50383-043_de69b3f3-56b3-4392-998c-1b0352a2fdc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form SOLUTION
Route ORAL
Labeler Akorn
Application ANDA040613
Marketing category ANDA
Marketing start 2008-02-08
Marketing end 0000-00-00
Substance HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength 2 mg/5mL; mg/5mL
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
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 A040613-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG/5ML;5MG/5ML SYRUP / ORAL 2008-02-08
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 A040613-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL 2008-02-08 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 50383-043-16 Hydrocodone Bitartrate and Homatropine Methylbromide 473 mL in 1 BOTTLE SOLUTION 473 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMATROPINE METHYLBROMIDE ACTIVE INGREDIENT 68JRS2HC1C HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 METHYLHOMATROPINE ACTIVE MOIETY P97OGJ7L1L HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 CARAMEL INACTIVE INGREDIENT T9D99G2B1R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 CHERRY INACTIVE INGREDIENT BUC5I9595W HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 SORBITOL INACTIVE INGREDIENT 506T60A25R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.] 9 HOMATROPINE METHYLBROMIDE ACTIVE INGREDIENT 68JRS2HC1C HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 3 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 3 HOMATROPINE ACTIVE MOIETY 8QS6WCL55Z HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 3 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.] 3 HOMATROPINE METHYLBROMIDE ACTIVE INGREDIENT 68JRS2HC1C HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 HOMATROPINE ACTIVE MOIETY 8QS6WCL55Z HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 CHERRY INACTIVE INGREDIENT BUC5I9595W HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-043 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [AKORN] 21 Legacy NDC, 1 package rows 20220312_7d45e534-338b-4c98-b85f-edd19a287e14.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 50383-043-16 50383004316 473 mL in 1 BOTTLE (50383-043-16) 473 ml 2008-02-08 0000-00-00 No No Current