Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 50268-774
- 11-digit product format
- 502680774
- Labeler code
- 50268
- Product ID
- 50268-774_48365501-3c10-9da0-e063-6394a90a25d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2015-01-14
- Marketing end
- 2027-03-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride and Acetaminophen
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 |
|---|
| 50268-774-11 | Tramadol Hydrochloride and Acetaminophen | 1 in 1 BLISTER PACK | TABLET | 1 | | 6 |
| 50268-774-15 | Tramadol Hydrochloride and Acetaminophen | 50 in 1 BOX | TABLET | 50 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-774 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AVPAK] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240110_244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-774-11 | 50268077411 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-774-15 | 50268077415 | 50 BLISTER PACK in 1 BOX (50268-774-15) / 1 TABLET in 1 BLISTER PACK (50268-774-11) | 50 blister pack | 2015-01-14 | 2027-03-31 | No | No | Current |