Carbamazepine
- Product NDC
- 68084-444
- 11-digit product format
- 680840444
- Labeler code
- 68084
- Product ID
- 68084-444_2515a881-5a14-86cf-e063-6394a90a5c47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carbamazepine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA075948
- Marketing category
- ANDA
- Marketing start
- 2023-06-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carbamazepine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 308979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-444-01 | Carbamazepine | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 7 |
| 68084-444-11 | Carbamazepine | 1 in 1 BLISTER PACK | TABLET | 1 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-444 | CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241025_1dd3d934-efee-4fdb-ae6f-f47b61831a2e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68084-444-01 | 68084044401 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-444-01) / 1 TABLET in 1 BLISTER PACK (68084-444-11) | 100 blister pack | 2023-06-02 | No | No | Current |
| 68084-444-11 | 68084044411 | 1 in 1 BLISTER PACK | | | | | Historical |