CARBAMAZEPINE
- Product NDC
- 70518-3591
- 11-digit product format
- 705183591
- Labeler code
- 70518
- Product ID
- 70518-3591_f0d1538d-1c39-1a56-e053-2a95a90a5766
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211623
- Marketing category
- ANDA
- Marketing start
- 2022-12-07
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 400 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3591-0 | 70518359100 | 100 POUCH in 1 BOX (70518-3591-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3591-1) | 100 pouch | 2022-12-07 | 0000-00-00 | No | No | Current |