Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 68382-334
- 11-digit product format
- 683820334
- Labeler code
- 68382
- Product ID
- 68382-334_09e59579-9804-4511-b04f-2bf1146a3e82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA090460
- Marketing category
- ANDA
- Marketing start
- 2012-10-15
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TRAMADOL HYDROCHLORIDE | ACTIVE INGREDIENT | 9N7R477WCK | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TRAMADOL | ACTIVE MOIETY | 39J1LGJ30J | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIRECT RX (TRAMADOL ACETAMINOPHEN) TABLET [DIRECT RX] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-334 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 12 | Legacy NDC | 20230917_b7ea5b95-297d-4df6-9480-62c83ba33fb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-334-01 | 68382033401 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-334-01) | 2012-10-15 | 0000-00-00 | No | No | Current |
| 68382-334-05 | 68382033405 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-334-05) | 2012-10-15 | 0000-00-00 | No | No | Current |
| 68382-334-10 | 68382033410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-334-10) | 2012-10-15 | 0000-00-00 | No | No | Current |