TRAMADOL HYDROCHLORIDE
- Product NDC
- 76420-536
- 11-digit product format
- 764200536
- Labeler code
- 76420
- Product ID
- 76420-536_f4ca3781-8aec-9696-e053-2a95a90adf9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA200503
- Marketing category
- ANDA
- Marketing start
- 2014-08-19
- 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 |
|---|
| 76420-536-30 | 76420053630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-30) | 2023-02-16 | No | No | Historical |
| 76420-536-60 | 76420053660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-60) | 2023-02-16 | No | No | Historical |
| 76420-536-90 | 76420053690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-90) | 2023-02-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TRAMADOL HYDROCHLORIDE | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-02-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |