FDA.reportPublic FDA data

Carbatrol

Product NDC
54092-173
11-digit product format
540920173
Labeler code
54092
Product ID
54092-173_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
1997-09-30
Substance
CARBAMAZEPINE
Active strength
300 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
IngredientStrength
CARBAMAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui200131, 200133, 308977, 313931, 388311, 404742

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-173-12Carbatrol120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-173-12EA - Each54092-173563204de-d7f9-4ff3-8de2-eeb4f4fa826412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
GELATININACTIVE INGREDIENT2G86QN327LCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
TALCINACTIVE INGREDIENT7SEV7J4R1UCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [SHIRE US MANUFACTURING INC.]26
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-173CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]38Current NDC, Legacy NDC, 1 package rows20230422_bc03e499-5bac-4293-bff4-6864153a624d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
404742Carbatrol 100 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
308977Carbatrol 200 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
313931Carbatrol 300 MG 12HR Extended Release Oral CapsulePSNbc03e499-5bac-4293-bff4-6864153a624d39
40474212 HR carbamazepine 100 MG Extended Release Oral Capsule [Carbatrol]SBDbc03e499-5bac-4293-bff4-6864153a624d39
30897712 HR carbamazepine 200 MG Extended Release Oral Capsule [Carbatrol]SBDbc03e499-5bac-4293-bff4-6864153a624d39
31393112 HR carbamazepine 300 MG Extended Release Oral Capsule [Carbatrol]SBDbc03e499-5bac-4293-bff4-6864153a624d39
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDbc03e499-5bac-4293-bff4-6864153a624d39
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDbc03e499-5bac-4293-bff4-6864153a624d39
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDbc03e499-5bac-4293-bff4-6864153a624d39
40474212 HR Carbatrol 100 MG Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
30897712 HR Carbatrol 200 MG Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
31393112 HR Carbatrol 300 MG Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
404742Carbatrol 100 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
308977Carbatrol 200 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
313931Carbatrol 300 MG 12 HR Extended Release Oral CapsuleSYbc03e499-5bac-4293-bff4-6864153a624d39
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNfbf67fc8-8d29-4ae2-a533-75461754c5b14
313931Carbatrol 300 MG 12HR Extended Release Oral CapsulePSNfbf67fc8-8d29-4ae2-a533-75461754c5b14
31393112 HR carbamazepine 300 MG Extended Release Oral Capsule [Carbatrol]SBDfbf67fc8-8d29-4ae2-a533-75461754c5b14
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDfbf67fc8-8d29-4ae2-a533-75461754c5b14
31393112 HR Carbatrol 300 MG Extended Release Oral CapsuleSYfbf67fc8-8d29-4ae2-a533-75461754c5b14
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYfbf67fc8-8d29-4ae2-a533-75461754c5b14
313931Carbatrol 300 MG 12 HR Extended Release Oral CapsuleSYfbf67fc8-8d29-4ae2-a533-75461754c5b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-173-1254092017312120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12) 1997-09-300000-00-00NoNoCurrent