FDA.reportPublic FDA data

Carbamazepine

Product NDC
67046-1534
11-digit product format
670461534
Labeler code
67046
Product ID
67046-1534_30b755a0-6565-ebf3-e063-6294a90a07b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler, LLC
Application
ANDA078115
Marketing category
ANDA
Marketing start
2025-03-19
Substance
CARBAMAZEPINE
Active strength
400 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
CARBAMAZEPINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui402506

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
67046-1534-3Carbamazepine30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1534CARBAMAZEPINE TABLET, EXTENDED RELEASE [COUPLER, LLC]1Current NDC, 1 package rows20250322_30b75584-3a1c-c125-e063-6294a90acaa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN30b75584-3a1c-c125-e063-6294a90acaa71
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD30b75584-3a1c-c125-e063-6294a90acaa71
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY30b75584-3a1c-c125-e063-6294a90acaa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1534-36704615340330 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1534-3) 2025-03-19NoNoHistorical