FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
0904-6172
11-digit product format
009046172
Labeler code
0904
Product ID
0904-6172_4da43d38-dcd6-4447-8693-5e41e78aacbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077272
Marketing category
ANDA
Marketing start
2010-09-20
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
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
CARBAMAZEPINE200 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
0904-6172-50CARBAMAZEPINE2000 in 1 BOTTLETABLET200027
0904-6172-61CARBAMAZEPINE1 in 1 BLISTER PACKTABLET127
0904-6172-61CARBAMAZEPINE100 in 1 CARTONTABLET10027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6172-50EA - Each0904-61729e4f6889-9ae4-4431-a215-dfb5e00f59de12017-08-11
0904-6172-61EA - Each0904-6172f35e95fe-9695-4bdc-9e90-0064eede062712013-02-13

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 [CARDINAL HEALTH]5
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET [CARDINAL HEALTH]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE TABLET [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [CARDINAL HEALTH]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET [CARDINAL HEALTH]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBAMAZEPINE TABLET [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET [CARDINAL HEALTH]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6172CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET [MAJOR PHARMACEUTICALS]24Current NDC, Legacy NDC, 3 package rows20250507_2a8c7366-ce89-47ce-8123-96f26812fca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
308979carBAMazepine 200 MG Oral TabletPSN232ef732-ee6d-4ac7-8e78-c619b611fbbe14
308979carbamazepine 200 MG Oral TabletSCD232ef732-ee6d-4ac7-8e78-c619b611fbbe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6172-50009046172502000 TABLET in 1 BOTTLE (0904-6172-50) 2000 tablet2010-09-200000-00-00NoNoCurrent
0904-6172-6100904617261100 BLISTER PACK in 1 CARTON (0904-6172-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2010-09-200000-00-00NoNoCurrent