| Product NDC: | 76519-1009 |
| Proprietary Name: | Tramadol Hydrochloride |
| Non Proprietary Name: | Tramadol Hydrochloride |
| Active Ingredient(s): | 150 mg/1 & nbsp; Tramadol Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 76519-1009 |
| Labeler Name: | H.J. Harkins Company, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022370 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120314 |
| Package NDC: | 76519-1009-9 |
| Package Description: | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-9) |
| NDC Code | 76519-1009-9 |
| Proprietary Name | Tramadol Hydrochloride |
| Package Description | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-9) |
| Product NDC | 76519-1009 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Tramadol Hydrochloride |
| Dosage Form Name | CAPSULE, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20120314 |
| Marketing Category Name | NDA |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Strength Number | 150 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |