Carbamazepine

Product NDC
71335-0461
11-digit product format
713350461
Labeler code
71335
Product ID
71335-0461_bf0f299f-4d58-443f-a66e-e231287bbbdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
Substance
CARBAMAZEPINE
Active strength
200 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
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

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
71335-0461-1Carbamazepine30 in 1 BOTTLETABLET307
71335-0461-2Carbamazepine60 in 1 BOTTLETABLET607
71335-0461-3Carbamazepine90 in 1 BOTTLETABLET907
71335-0461-4Carbamazepine120 in 1 BOTTLETABLET1207
71335-0461-5Carbamazepine240 in 1 BOTTLETABLET2407
71335-0461-6Carbamazepine180 in 1 BOTTLETABLET1807
71335-0461-7Carbamazepine100 in 1 BOTTLETABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0461CARBAMAZEPINE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 7 package rows20240601_2d2c5317-4072-477b-a4e2-f6765fc71657.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN2d2c5317-4072-477b-a4e2-f6765fc716577
308979carbamazepine 200 MG Oral TabletSCD2d2c5317-4072-477b-a4e2-f6765fc716577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0461-17133504610130 TABLET in 1 BOTTLE (71335-0461-1) 30 tablet2020-07-130000-00-00NoNoCurrent
71335-0461-27133504610260 TABLET in 1 BOTTLE (71335-0461-2) 60 tablet2024-05-290000-00-00NoNoCurrent
71335-0461-37133504610390 TABLET in 1 BOTTLE (71335-0461-3) 90 tablet2024-05-290000-00-00NoNoCurrent
71335-0461-471335046104120 TABLET in 1 BOTTLE (71335-0461-4) 120 tablet2024-05-290000-00-00NoNoCurrent
71335-0461-571335046105240 TABLET in 1 BOTTLE (71335-0461-5) 240 tablet2024-05-290000-00-00NoNoCurrent
71335-0461-671335046106180 TABLET in 1 BOTTLE (71335-0461-6) 180 tablet2024-05-290000-00-00NoNoCurrent
71335-0461-771335046107100 TABLET in 1 BOTTLE (71335-0461-7) 100 tablet2025-09-16NoNoCurrent