FDA.reportPublic FDA data

Carbamazepine

Product NDC
46708-421
11-digit product format
467080421
Labeler code
46708
Product ID
46708-421_1fc170d7-db1a-486d-8c10-faa6e3da3b1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA219939
Marketing category
ANDA
Marketing start
2025-07-26
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
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
CARBAMAZEPINE200 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-421-31Carbamazepine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
46708-421-91Carbamazepine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY1fc170d7-db1a-486d-8c10-faa6e3da3b1e1
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY1fc170d7-db1a-486d-8c10-faa6e3da3b1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-421-3146708042131100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-421-31) 2025-07-26NoNoCurrent
46708-421-91467080421911000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-421-91) 2025-07-26NoNoCurrent