Tramadol Hydrochloride
- Product NDC
- 76420-734
- 11-digit product format
- 764200734
- Labeler code
- 76420
- Product ID
- 76420-734_3c537239-67e9-1101-e063-6394a90a397f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA208708
- Marketing category
- ANDA
- Marketing start
- 2020-02-24
- Substance
- TRAMADOL HYDROCHLORIDE
- Active strength
- 100 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9N7R477WCK | TRAMADOL HYDROCHLORIDE | 36282-47-0 | TRAMADOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-734-00 | 76420073400 | 1000 TABLET, COATED in 1 BOTTLE (76420-734-00) | 2024-05-22 | No | No | Historical |
| 76420-734-01 | 76420073401 | 100 TABLET, COATED in 1 BOTTLE (76420-734-01) | 2024-05-22 | No | No | Historical |
| 76420-734-05 | 76420073405 | 500 TABLET, COATED in 1 BOTTLE (76420-734-05) | 2024-05-22 | No | No | Historical |
| 76420-734-30 | 76420073430 | 30 TABLET, COATED in 1 BOTTLE (76420-734-30) | 2024-05-22 | No | No | Historical |
| 76420-734-60 | 76420073460 | 60 TABLET, COATED in 1 BOTTLE (76420-734-60) | 2024-05-22 | No | No | Historical |
| 76420-734-90 | 76420073490 | 90 TABLET, COATED in 1 BOTTLE (76420-734-90) | 2024-05-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tramadol Hydrochloride | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 3 |