Tramadol Hydrochloride
- Product NDC
- 68788-4040
- 11-digit product format
- 687884040
- Labeler code
- 68788
- Product ID
- 68788-4040_f558c59c-cbd4-4b17-9a3d-b014ad09bbb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA211825
- Marketing category
- ANDA
- Marketing start
- 2025-10-13
- 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
- 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 |
|---|
| 68788-4040-1 | 68788404001 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-1) | 2025-10-13 | No | No | Historical |
| 68788-4040-2 | 68788404002 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-2) | 2025-10-13 | No | No | Historical |
| 68788-4040-3 | 68788404003 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-3) | 2025-10-13 | No | No | Historical |
| 68788-4040-4 | 68788404004 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-4) | 2025-10-13 | No | No | Historical |
| 68788-4040-5 | 68788404005 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-5) | 2025-10-13 | No | No | Historical |
| 68788-4040-6 | 68788404006 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-6) | 2025-10-13 | No | No | Historical |
| 68788-4040-7 | 68788404007 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-7) | 2025-10-13 | No | No | Historical |
| 68788-4040-8 | 68788404008 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-8) | 2025-10-13 | No | No | Historical |
| 68788-4040-9 | 68788404009 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-9) | 2025-10-13 | No | No | Historical |