FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
13668-271
11-digit product format
136680271
Labeler code
13668
Product ID
13668-271_2b305f64-7c1a-4cf6-a4ad-57326eb4c874
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA075712
Marketing category
ANDA
Marketing start
2009-08-26
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
CARBAMAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308973, 308979

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
13668-271-01CARBAMAZEPINE100 in 1 BOTTLETABLET, CHEWABLE10022
13668-271-05CARBAMAZEPINE500 in 1 BOTTLETABLET, CHEWABLE50022
13668-271-10CARBAMAZEPINE1000 in 1 BOTTLETABLET, CHEWABLE100022
13668-271-49CARBAMAZEPINE750 in 1 BOTTLETABLET, CHEWABLE75022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-271-01EA - Each13668-271fa728c2c-69b5-4397-bf27-7254b26adda112012-07-24
13668-271-05EA - Each13668-2712dc90b7a-0983-4712-9867-ba558c6ca05212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]12
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]9
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-271CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]21Current NDC, Legacy NDC, 4 package rows20250223_97e6e175-75e8-437b-b457-ddb1ae4e857d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNc72a0668-7cd7-46a8-86d1-d3c17c4b900f101
308973carbamazepine 100 MG Chewable TabletSCDc72a0668-7cd7-46a8-86d1-d3c17c4b900f101
308973carBAMazepine 100 MG Chewable TabletPSN2a8c7366-ce89-47ce-8123-96f26812fca027
308979carBAMazepine 200 MG Oral TabletPSN2a8c7366-ce89-47ce-8123-96f26812fca027
308973carbamazepine 100 MG Chewable TabletSCD2a8c7366-ce89-47ce-8123-96f26812fca027
308979carbamazepine 200 MG Oral TabletSCD2a8c7366-ce89-47ce-8123-96f26812fca027
308973carBAMazepine 100 MG Chewable TabletPSN97e6e175-75e8-437b-b457-ddb1ae4e857d22
308979carBAMazepine 200 MG Oral TabletPSN97e6e175-75e8-437b-b457-ddb1ae4e857d22
308973carbamazepine 100 MG Chewable TabletSCD97e6e175-75e8-437b-b457-ddb1ae4e857d22
308979carbamazepine 200 MG Oral TabletSCD97e6e175-75e8-437b-b457-ddb1ae4e857d22
308973carBAMazepine 100 MG Chewable TabletPSNf8444c23-a74f-4d44-867e-26554dbb882f6
308973carbamazepine 100 MG Chewable TabletSCDf8444c23-a74f-4d44-867e-26554dbb882f6
308973carBAMazepine 100 MG Chewable TabletPSN1d6698da-dacd-44e3-8af1-976bc7427de12
308973carbamazepine 100 MG Chewable TabletSCD1d6698da-dacd-44e3-8af1-976bc7427de12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-271-0113668027101100 TABLET, CHEWABLE in 1 BOTTLE (13668-271-01) 2009-08-260000-00-00NoNoCurrent
13668-271-0513668027105500 TABLET, CHEWABLE in 1 BOTTLE (13668-271-05) 2009-08-260000-00-00NoNoCurrent
13668-271-10136680271101000 TABLET, CHEWABLE in 1 BOTTLE (13668-271-10) 2009-08-260000-00-00NoNoCurrent
13668-271-4913668027149750 TABLET, CHEWABLE in 1 BOTTLE (13668-271-49) 2009-08-260000-00-00NoNoCurrent