Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 71205-625
- 11-digit product format
- 712050625
- Labeler code
- 71205
- Product ID
- 71205-625_10ab10fb-a693-47a4-9739-6bab1f192e9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA207152
- Marketing category
- ANDA
- Marketing start
- 2017-03-22
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325; 37.5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| TRAMADOL HYDROCHLORIDE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9N7R477WCK |
| Rxcui | 836395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-625-30 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 71205-625-60 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 71205-625-90 | Tramadol Hydrochloride and Acetaminophen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-625 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220612_d9fa3057-c7a5-46cf-a79e-abf99a4f804d.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 |
|---|
| 71205-625-30 | 71205062530 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-625-30) | 2021-12-15 | 0000-00-00 | No | No | Current |
| 71205-625-60 | 71205062560 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-625-60) | 2021-12-15 | 0000-00-00 | No | No | Current |
| 71205-625-90 | 71205062590 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-625-90) | 2021-12-15 | 0000-00-00 | No | No | Current |