FDA.reportPublic FDA data

Carbamazepine

Product NDC
71610-782
11-digit product format
716100782
Labeler code
71610
Product ID
71610-782_55bf83fb-d32e-4d7a-83aa-02d4b1ac6a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
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
Rxcui308979

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
71610-782-80Carbamazepine180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-782-80EA - Each71610-7822723b2b5-8d60-4092-81dc-ab55ae0ac1fb12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-782CARBAMAZEPINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 1 package rows20240202_697f3e5a-c84b-44a6-b9f3-15e7d9bb6395.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN697f3e5a-c84b-44a6-b9f3-15e7d9bb63951
308979carbamazepine 200 MG Oral TabletSCD697f3e5a-c84b-44a6-b9f3-15e7d9bb63951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-782-8071610078280180 TABLET in 1 BOTTLE (71610-782-80) 180 tablet2024-01-25NoNoHistorical