FDA.reportPublic FDA data

Carbamazepine

Product NDC
50268-172
11-digit product format
502680172
Labeler code
50268
Product ID
50268-172_47e2efaa-df8e-5401-e063-6394a90aae6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA078986
Marketing category
ANDA
Marketing start
2021-10-19
Substance
CARBAMAZEPINE
Active strength
300 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
CARBAMAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui200131, 200133, 388311

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
50268-172-11Carbamazepine1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE14
50268-172-13Carbamazepine30 in 1 BOXCAPSULE, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-172CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_ceb84aa4-2041-6e6e-e053-2995a90a0f24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNceb84aa4-2041-6e6e-e053-2995a90a0f244
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDceb84aa4-2041-6e6e-e053-2995a90a0f244
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYceb84aa4-2041-6e6e-e053-2995a90a0f244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-172-11502680172111 in 1 BLISTER PACKHistorical
50268-172-135026801721330 BLISTER PACK in 1 BOX (50268-172-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-172-11) 30 blister pack2021-10-190000-00-00NoNoCurrent