Tramadol Hydrochloride
- Product NDC
- 53002-4323
- 11-digit product format
- 530024323
- Labeler code
- 53002
- Product ID
- 53002-4323_8d805ff1-def3-4366-8d76-335f99b0fa35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tramadol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075986
- Marketing category
- ANDA
- Marketing start
- 2002-06-21
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-4323-1 | 53002432301 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-4323-1) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-4323-2 | 53002432302 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-4323-2) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-4323-3 | 53002432303 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-4323-3) | 2021-01-01 | 0000-00-00 | No | No | Current |