Carbamazepine
- Product NDC
- 72516-020
- 11-digit product format
- 725160020
- Labeler code
- 72516
- Product ID
- 72516-020_51cbae90-fd98-2e08-e063-6294a90a1748
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Oryza Pharmaceuticals Inc.
- Application
- ANDA212948
- Marketing category
- ANDA
- Marketing start
- 2026-05-18
- Substance
- CARBAMAZEPINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 33CM23913M | CARBAMAZEPINE | 298-46-4 | CARBAMAZEPINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72516-020-01 | 72516002001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-020-01) | 2026-05-18 | No | No | Historical |