Product NDC: | 12634-909 |
Proprietary Name: | PROMETHAZINE WITH CODEINE |
Non Proprietary Name: | PROMETHAZINE WITH CODEINE |
Active Ingredient(s): | 10; 6.25 mg/5mL; mg/5mL & nbsp; PROMETHAZINE WITH CODEINE |
Administration Route(s): | ORAL |
Dosage Form(s): | LIQUID |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 12634-909 |
Labeler Name: | Apotheca, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040151 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090601 |
Package NDC: | 12634-909-02 |
Package Description: | 60 mL in 1 BOTTLE (12634-909-02) |
NDC Code | 12634-909-02 |
Proprietary Name | PROMETHAZINE WITH CODEINE |
Package Description | 60 mL in 1 BOTTLE (12634-909-02) |
Product NDC | 12634-909 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PROMETHAZINE WITH CODEINE |
Dosage Form Name | LIQUID |
Route Name | ORAL |
Start Marketing Date | 20090601 |
Marketing Category Name | ANDA |
Labeler Name | Apotheca, Inc. |
Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
Strength Number | 10; 6.25 |
Strength Unit | mg/5mL; mg/5mL |
Pharmaceutical Classes | Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |