FDA.reportPublic FDA data

Carbamazepine

Product NDC
50742-259
11-digit product format
507420259
Labeler code
50742
Product ID
50742-259_51f0f49a-c1ef-4ccd-8872-001241d81f81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA216404
Marketing category
ANDA
Marketing start
2023-08-01
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
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
50742-259-01Carbamazepine100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-259-01EA - Each50742-2596456538f-b6f7-4331-a62a-71c6e934ffde12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-259CARBAMAZEPINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]5Current NDC, 1 package rows20241024_de67de85-15b3-4c27-b604-d028ce3789d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSNde67de85-15b3-4c27-b604-d028ce3789d07
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSNde67de85-15b3-4c27-b604-d028ce3789d07
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSNde67de85-15b3-4c27-b604-d028ce3789d07
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCDde67de85-15b3-4c27-b604-d028ce3789d07
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCDde67de85-15b3-4c27-b604-d028ce3789d07
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCDde67de85-15b3-4c27-b604-d028ce3789d07
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSYde67de85-15b3-4c27-b604-d028ce3789d07
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSYde67de85-15b3-4c27-b604-d028ce3789d07
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSYde67de85-15b3-4c27-b604-d028ce3789d07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50742-259-0150742025901100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-259-01) 2023-08-01NoNoHistorical