TRAMADOL HYDROCHLORIDE
- Product NDC
- 76420-127
- 11-digit product format
- 764200127
- Labeler code
- 76420
- Product ID
- 76420-127_add5be5e-957e-fe25-e053-2995a90a6927
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA091498
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-127 | TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Legacy NDC | 20200828_a58f61ed-b542-4aac-a056-718e54134d5c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-127-30 | 76420012730 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-127-30) | 2020-08-27 | 0000-00-00 | No | No | Current |
| 76420-127-60 | 76420012760 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-127-60) | 2020-08-27 | 0000-00-00 | No | No | Current |