Carbamazepine

Product NDC
60687-479
11-digit product format
606870479
Labeler code
60687
Product ID
60687-479_45383876-8944-0ac1-e063-6294a90a861d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075712
Marketing category
ANDA
Marketing start
2020-01-03
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

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
60687-479-01Carbamazepine100 in 1 BOX, UNIT-DOSETABLET, CHEWABLE1006
60687-479-11Carbamazepine1 in 1 BLISTER PACKTABLET, CHEWABLE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-479-01EA - Each60687-479559fa462-9262-4f65-b483-b6b504b947e812020-02-13
60687-479-11EA - Each60687-4798802e12f-1513-4a72-8845-c03c7d0f1dcd12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-479CARBAMAZEPINE TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241027_f8444c23-a74f-4d44-867e-26554dbb882f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNf8444c23-a74f-4d44-867e-26554dbb882f6
308973carbamazepine 100 MG Chewable TabletSCDf8444c23-a74f-4d44-867e-26554dbb882f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-479-0160687047901100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-479-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (60687-479-11) 100 blister pack2020-01-030000-00-00NoNoCurrent
60687-479-11606870479111 in 1 BLISTER PACKHistorical