Tramadol HCl and Acetaminophen
- Product NDC
- 67877-322
- 11-digit product format
- 678770322
- Labeler code
- 67877
- Product ID
- 67877-322_34498c95-abf4-4ff5-8b9d-2e762aab0d20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol HCl and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA202076
- Marketing category
- ANDA
- Marketing start
- 2016-06-15
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-322-01 | Tramadol HCl and Acetaminophen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 67877-322-05 | Tramadol HCl and Acetaminophen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 67877-322-10 | Tramadol HCl and Acetaminophen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-322 | TRAMADOL HCL AND ACETAMINOPHEN TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 1 | Legacy NDC, 3 package rows | 20160616_34498c95-abf4-4ff5-8b9d-2e762aab0d20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67877-322-01 | 67877032201 | 100 in 1 BOTTLE | Historical |
| 67877-322-05 | 67877032205 | 500 in 1 BOTTLE | Historical |
| 67877-322-10 | 67877032210 | 1000 in 1 BOTTLE | Historical |