Product NDC: | 68387-100 |
Proprietary Name: | Propoxyphene and Acetaminophen |
Non Proprietary Name: | propoxyphene napsylate and acetaminophen |
Active Ingredient(s): | 650; 100 mg/1; mg/1 & nbsp; propoxyphene napsylate and acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68387-100 |
Labeler Name: | Keltman Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA074843 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090301 |
Package NDC: | 68387-100-50 |
Package Description: | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-50) |
NDC Code | 68387-100-50 |
Proprietary Name | Propoxyphene and Acetaminophen |
Package Description | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-50) |
Product NDC | 68387-100 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | propoxyphene napsylate and acetaminophen |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20090301 |
Marketing Category Name | ANDA |
Labeler Name | Keltman Pharmaceuticals Inc. |
Substance Name | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE |
Strength Number | 650; 100 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |