tramadol hydrochloride
- Product NDC
- 57664-377
- 11-digit product format
- 576640377
- Labeler code
- 57664
- Product ID
- 57664-377_ec6ca108-bbe1-46af-e053-2995a90a04c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075964
- Marketing category
- ANDA
- Marketing start
- 2002-06-22
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-377 | TRAMADOL HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 28 | Legacy NDC | 20250114_cabccc8a-6f9f-414c-93f0-6dec331ed74b.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 |
|---|
| 57664-377-08 | 57664037708 | 100 TABLET in 1 BOTTLE (57664-377-08) | 100 tablet | 2002-06-22 | 0000-00-00 | No | No | Current |
| 57664-377-13 | 57664037713 | 500 TABLET in 1 BOTTLE (57664-377-13) | 500 tablet | 2002-06-22 | 0000-00-00 | No | No | Current |
| 57664-377-18 | 57664037718 | 1000 TABLET in 1 BOTTLE (57664-377-18) | 1000 tablet | 2002-06-22 | 0000-00-00 | No | No | Current |