Product NDC: | 0121-4811 |
Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
Non Proprietary Name: | Hydrocodone Bitartrate and Homatropine Methylbromide |
Active Ingredient(s): | 1.5; 5 mg/5mL; mg/5mL & nbsp; Hydrocodone Bitartrate and Homatropine Methylbromide |
Administration Route(s): | ORAL |
Dosage Form(s): | SYRUP |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0121-4811 |
Labeler Name: | Pharmaceutical Associates, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA088008 |
Marketing Category: | ANDA |
Start Marketing Date: | 20091228 |
Package NDC: | 0121-4811-05 |
Package Description: | 4 TRAY in 1 CASE (0121-4811-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE |
NDC Code | 0121-4811-05 |
Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
Package Description | 4 TRAY in 1 CASE (0121-4811-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE |
Product NDC | 0121-4811 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocodone Bitartrate and Homatropine Methylbromide |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20091228 |
Marketing Category Name | ANDA |
Labeler Name | Pharmaceutical Associates, Inc. |
Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
Strength Number | 1.5; 5 |
Strength Unit | mg/5mL; mg/5mL |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |