CARBAMAZEPINE
- Product NDC
- 53808-0858
- 11-digit product format
- 538080858
- Labeler code
- 53808
- Product ID
- 53808-0858_a1e16d44-3bdd-4efd-bad2-9416a826be83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CARBAMAZEPINE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA075712
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- CARBAMAZEPINE
- Active strength
- 100 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0858-1 | CARBAMAZEPINE | 30 in 1 BLISTER PACK | TABLET, CHEWABLE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0858 | CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20140402_1d6698da-dacd-44e3-8af1-976bc7427de1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0858-1 | 53808085801 | 30 in 1 BLISTER PACK | Historical |