FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
60429-032
11-digit product format
604290032
Labeler code
60429
Product ID
60429-032_447158f8-e728-773a-e063-6394a90ae7e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075948
Marketing category
ANDA
Marketing start
2002-02-27
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
60429-032-01CARBAMAZEPINE100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-032-01EA - Each60429-0329eaaf05d-ca2d-4cff-bbb9-e543d095a5a212014-06-03
60429-032-10EA - Each60429-032c75e1280-ac08-4326-b629-e02e6550261712014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-032CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]12Current NDC, Legacy NDC, 1 package rows20240302_9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN9fca7d59-dd9e-4fd8-bf34-e2f7e5a3680113
308979carbamazepine 200 MG Oral TabletSCD9fca7d59-dd9e-4fd8-bf34-e2f7e5a3680113
308979carBAMazepine 200 MG Oral TabletPSNc1fc31ef-6b2e-4de4-a185-ec44e94e7b401
308979carbamazepine 200 MG Oral TabletSCDc1fc31ef-6b2e-4de4-a185-ec44e94e7b401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-032-0160429003201100 TABLET in 1 BOTTLE (60429-032-01) 100 tablet2014-03-070000-00-00NoNoCurrent
60429-032-10604290032101000 TABLET in 1 BOTTLE (60429-032-10) 1000 tablet2014-03-072021-09-30NoNoCurrent