FDA.reportPublic FDA data

Carbamazepine

Product NDC
33261-676
11-digit product format
332610676
Labeler code
33261
Product ID
33261-676_2b8c4ae6-ba9f-43d3-93d1-e731b10a0a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-676-602020-01-31C16284748780-19d75b9d1-0b10-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carisoprodol safely and effectively. See full prescribing information for carisoprodol tablets, USP. Carisoprodol Tablets, USP for Oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-676-60Carbamazepine60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-676-60EA - Each33261-67618074824-2535-48f8-aa1b-a18b3f7dc05312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-676CARBAMAZEPINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20120913_80be25d9-2e4c-4e7c-b924-9cffbcf87b9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN80be25d9-2e4c-4e7c-b924-9cffbcf87b9e1
308979carbamazepine 200 MG Oral TabletSCD80be25d9-2e4c-4e7c-b924-9cffbcf87b9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-676-603326106766060 in 1 BOTTLEHistorical