CARBAMAZEPINE
- Product NDC
- 58118-0268
- 11-digit product format
- 581180268
- Labeler code
- 58118
- Product ID
- 58118-0268_ae7ecc37-9218-7746-e053-2995a90a675c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale
- Application
- ANDA077272
- Marketing category
- ANDA
- Marketing start
- 2009-10-23
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-0268 | CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE] | 8 | Legacy NDC | 20200905_e36ece79-544b-43b2-8cf9-ca9861b071b5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58118-0268-8 | 58118026808 | 30 TABLET in 1 BLISTER PACK (58118-0268-8) | 30 tablet | 2009-10-23 | 0000-00-00 | No | No | Current |