Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 45865-170
- 11-digit product format
- 458650170
- Labeler code
- 45865
- Product ID
- 45865-170_12f113b3-d6b2-a7b0-e063-6294a90a999d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- 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 |
|---|
| 45865-170-60 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-170 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20240307_12f113b3-d6b1-a7b0-e063-6294a90a999d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 45865-170-60 | 45865017060 | 60 TABLET, FILM COATED in 1 BOTTLE (45865-170-60) | 2021-03-08 | No | No | Current |