CARBAMAZEPINE

Product NDC
71205-025
11-digit product format
712050025
Labeler code
71205
Product ID
71205-025_9a099066-50bb-4651-bce7-5e1dc8e2e5b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075948
Marketing category
ANDA
Marketing start
2002-09-01
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
71205-025-30CARBAMAZEPINE30 in 1 BOTTLETABLET303
71205-025-60CARBAMAZEPINE60 in 1 BOTTLETABLET603
71205-025-90CARBAMAZEPINE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-025-90EA - Each71205-025234bc01a-d4dd-4ca3-bb01-0e31c293ae2612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-025CARBAMAZEPINE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191101_bf61798e-c07e-4959-909a-2b4c2c83b532.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSNbf61798e-c07e-4959-909a-2b4c2c83b5323
308979carbamazepine 200 MG Oral TabletSCDbf61798e-c07e-4959-909a-2b4c2c83b5323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-025-307120500253030 TABLET in 1 BOTTLE (71205-025-30) 30 tablet2018-05-010000-00-00NoNoCurrent
71205-025-607120500256060 TABLET in 1 BOTTLE (71205-025-60) 60 tablet2018-05-010000-00-00NoNoCurrent
71205-025-907120500259090 TABLET in 1 BOTTLE (71205-025-90) 90 tablet2018-05-010000-00-00NoNoCurrent