FDA.reportPublic FDA data

Carbamazepine

Product NDC
60429-934
11-digit product format
604290934
Labeler code
60429
Product ID
60429-934_4b3312bc-fde8-8277-e063-6394a90a17b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075687
Marketing category
ANDA
Marketing start
2000-10-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308973

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
60429-934-05Carbamazepine500 in 1 BOTTLETABLET, CHEWABLE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-934-05EA - Each60429-9345ef41afa-e3b2-4bab-b719-04cc30efb57c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE SUSPENSION CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-934CARBAMAZEPINE TABLET, CHEWABLE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 1 package rows20250119_536811ab-308b-4866-9185-9e4149483512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSN536811ab-308b-4866-9185-9e414948351210
308973carbamazepine 100 MG Chewable TabletSCD536811ab-308b-4866-9185-9e414948351210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-934-0560429093405500 TABLET, CHEWABLE in 1 BOTTLE (60429-934-05) 2011-07-200000-00-00NoNoCurrent