Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 45865-469
- 11-digit product format
- 458650469
- Labeler code
- 45865
- Product ID
- 45865-469_9ab28852-3e3c-308b-e053-2a95a90ae192
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- 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]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 45865-469-30 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 45865-469-40 | Tramadol Hydrochloride and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | | 2 |
| 45865-469-60 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-469 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 3 package rows | 20191228_1b67c155-5a0d-2202-e054-00144ff8d46c.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 |
|---|
| 45865-469-30 | 45865046930 | 30 TABLET in 1 BOTTLE (45865-469-30) | 30 tablet | 2015-07-22 | 0000-00-00 | No | No | Current |
| 45865-469-40 | 45865046940 | 40 TABLET in 1 BOTTLE (45865-469-40) | 40 tablet | 2015-07-22 | 0000-00-00 | No | No | Current |
| 45865-469-60 | 45865046960 | 60 TABLET in 1 BOTTLE (45865-469-60) | 60 tablet | 2015-07-22 | 0000-00-00 | No | No | Current |