CARBAMAZEPINE

Product NDC
72162-2572
11-digit product format
721622572
Labeler code
72162
Product ID
72162-2572_c6050a23-3446-423e-94da-0054ef635aa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075712
Marketing category
ANDA
Marketing start
2009-08-26
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
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
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
72162-2572-1CARBAMAZEPINE100 in 1 BOTTLETABLET, CHEWABLE100101
72162-2572-5CARBAMAZEPINE500 in 1 BOTTLETABLET, CHEWABLE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2572-1EA - Each72162-25726f631aea-d167-4459-892d-5a39f597c64912026-01-08
72162-2572-5EA - Each72162-25726efb1ab5-ee0a-44e0-a54d-e77f9c5ae45912026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSNc72a0668-7cd7-46a8-86d1-d3c17c4b900f101
308973carbamazepine 100 MG Chewable TabletSCDc72a0668-7cd7-46a8-86d1-d3c17c4b900f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2572-172162257201100 TABLET, CHEWABLE in 1 BOTTLE (72162-2572-1) 2025-11-17NoNoHistorical
72162-2572-572162257205500 TABLET, CHEWABLE in 1 BOTTLE (72162-2572-5) 2025-11-17NoNoHistorical