FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
71335-0691
11-digit product format
713350691
Labeler code
71335
Product ID
71335-0691_4cd41321-21e3-438b-b050-9767bbcfe0f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0691-1CARBAMAZEPINE30 in 1 BOTTLETABLET309
71335-0691-2CARBAMAZEPINE60 in 1 BOTTLETABLET609
71335-0691-3CARBAMAZEPINE90 in 1 BOTTLETABLET909
71335-0691-4CARBAMAZEPINE120 in 1 BOTTLETABLET1209
71335-0691-5CARBAMAZEPINE240 in 1 BOTTLETABLET2409
71335-0691-6CARBAMAZEPINE180 in 1 BOTTLETABLET1809
71335-0691-7CARBAMAZEPINE100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0691-1EA - Each71335-0691b7b70eb1-9f04-4a1c-a4e0-688efcbd840b12018-06-11
71335-0691-7EA - Each71335-069130612aa9-fab3-4d1d-81c3-e62379ef661812025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0691CARBAMAZEPINE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240410_45b355e6-9c19-4138-a1f8-53508e88f5a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN45b355e6-9c19-4138-a1f8-53508e88f5a99
308979carbamazepine 200 MG Oral TabletSCD45b355e6-9c19-4138-a1f8-53508e88f5a99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0691-17133506910130 TABLET in 1 BOTTLE (71335-0691-1) 30 tablet2018-02-150000-00-00NoNoCurrent
71335-0691-27133506910260 TABLET in 1 BOTTLE (71335-0691-2) 60 tablet2024-04-030000-00-00NoNoCurrent
71335-0691-37133506910390 TABLET in 1 BOTTLE (71335-0691-3) 90 tablet2024-04-030000-00-00NoNoCurrent
71335-0691-471335069104120 TABLET in 1 BOTTLE (71335-0691-4) 120 tablet2024-04-030000-00-00NoNoCurrent
71335-0691-571335069105240 TABLET in 1 BOTTLE (71335-0691-5) 240 tablet2024-04-030000-00-00NoNoCurrent
71335-0691-671335069106180 TABLET in 1 BOTTLE (71335-0691-6) 180 tablet2024-04-030000-00-00NoNoCurrent
71335-0691-771335069107100 TABLET in 1 BOTTLE (71335-0691-7) 100 tablet2024-04-03NoNoCurrent