FDA.reportPublic FDA data

Carbamazepine

Product NDC
62332-422
11-digit product format
623320422
Labeler code
62332
Product ID
62332-422_e1678991-b726-4e47-bb00-98c9d7277a1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA219939
Marketing category
ANDA
Marketing start
2025-07-26
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
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
CARBAMAZEPINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui199378, 402505, 402506

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
62332-422-31Carbamazepine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
62332-422-91Carbamazepine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-422-31EA - Each62332-4221333aa94-bfca-435c-9722-eb1c4176ea1012026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN726a127b-03b2-44e8-a63d-078b35e275255
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN726a127b-03b2-44e8-a63d-078b35e275255
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN726a127b-03b2-44e8-a63d-078b35e275255
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD726a127b-03b2-44e8-a63d-078b35e275255
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD726a127b-03b2-44e8-a63d-078b35e275255
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD726a127b-03b2-44e8-a63d-078b35e275255
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY726a127b-03b2-44e8-a63d-078b35e275255
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY726a127b-03b2-44e8-a63d-078b35e275255
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY726a127b-03b2-44e8-a63d-078b35e275255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-422-3162332042231100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-422-31) 2025-07-26NoNoCurrent
62332-422-91623320422911000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-422-91) 2025-07-26NoNoCurrent