Carbamazepine
- Product NDC
- 50090-0384
- 11-digit product format
- 500900384
- Labeler code
- 50090
- Product ID
- 50090-0384_8527de6f-92f0-4037-a597-26c4f9c006cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074649
- Marketing category
- ANDA
- Marketing start
- 1996-10-03
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0384-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
| 50090-0384-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
| 50090-0384-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
| 50090-0384-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
| 50090-0384-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
| 50090-0384-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-ad6a-0266-e053-dadaa90a7c1a | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-0384-0 | 50090038400 | 100 TABLET in 1 BOTTLE (50090-0384-0) | 100 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |
| 50090-0384-1 | 50090038401 | 60 TABLET in 1 BOTTLE (50090-0384-1) | 60 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |
| 50090-0384-3 | 50090038403 | 28 TABLET in 1 BOTTLE (50090-0384-3) | 28 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |