Tramadol Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Polygen Pharmaceuticals Inc.. The primary component is Tramadol Hydrochloride.
| Product ID | 52605-010_6d58111e-f9d8-403c-af24-139c9cab07e9 |
| NDC | 52605-010 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tramadol Hydrochloride |
| Generic Name | Tramadol Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-01-13 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206706 |
| Labeler Name | POLYGEN PHARMACEUTICALS INC. |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2015-01-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-01 |
| Marketing Category | ANDA |
| Application Number | ANDA206706 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-01 |
| Ingredient | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 50 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0058 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 0378-4151 | Tramadol Hydrochloride | tramadol hydrochloride |
| 0378-4152 | Tramadol Hydrochloride | tramadol hydrochloride |
| 0378-4153 | Tramadol Hydrochloride | tramadol hydrochloride |
| 0378-4154 | Tramadol Hydrochloride | tramadol hydrochloride |
| 0615-7810 | Tramadol Hydrochloride | tramadol hydrochloride |
| 0615-8005 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 0904-6365 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 0904-7179 | tramadol hydrochloride | tramadol hydrochloride |
| 10147-0901 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 10147-0902 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 10147-0903 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 10370-221 | Tramadol Hydrochloride | tramadol hydrochloride |
| 10370-222 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 10370-223 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 10544-009 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 10544-531 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 12634-786 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-3280 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-1978 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68071-3321 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-4119 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68071-4165 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-4154 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-4070 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68071-4282 | tramadol hydrochloride | tramadol hydrochloride |
| 68084-808 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68071-4802 | tramadol hydrochloride | tramadol hydrochloride |
| 68094-017 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68180-698 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68180-699 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68180-697 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68258-2003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68382-319 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68387-900 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68788-7321 | tramadol hydrochloride | tramadol hydrochloride |
| 68788-9199 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68788-6929 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68788-8921 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68788-7284 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68788-7373 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68788-8920 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 68788-9232 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 68788-9237 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
| 69150-020 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 69420-5150 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 69467-1001 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 69543-136 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 69677-316 | Tramadol Hydrochloride | Tramadol Hydrochloride |
| 70518-0054 | Tramadol Hydrochloride | Tramadol Hydrochloride |