Carbatrol
- Product NDC
- 54092-171
- 11-digit product format
- 540920171
- Labeler code
- 54092
- Product ID
- 54092-171_39171a32-c78d-4130-be53-638e19cf2261
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carbamazepine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA020712
- Marketing category
- NDA
- Marketing start
- 1999-12-22
- Substance
- CARBAMAZEPINE
- Active strength
- 100 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
- Carbatrol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBAMAZEPINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33CM23913M |
| Rxcui | 200131, 200133, 308977, 313931, 388311, 404742 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54092-171-12 | Carbatrol | 120 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 120 | | 39 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARBAMAZEPINE | ACTIVE INGREDIENT | 33CM23913M | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| CARBAMAZEPINE | ACTIVE MOIETY | 33CM23913M | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.] | 26 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54092-171 | CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 38 | Current NDC, Legacy NDC, 1 package rows | 20230422_bc03e499-5bac-4293-bff4-6864153a624d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54092-171-12 | 54092017112 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12) | 1999-12-22 | 0000-00-00 | No | No | Current |