| 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: | 68387-100-10 | 
| Package Description: | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-10) | 
| NDC Code | 68387-100-10 | 
| Proprietary Name | Propoxyphene and Acetaminophen | 
| Package Description | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68387-100-10) | 
| 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] |