Carbamazepine

Product NDC
67046-086
11-digit product format
670460086
Labeler code
67046
Product ID
67046-086_8e06995c-26c9-4ef3-9421-16a2360db628
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA070541
Marketing category
ANDA
Marketing start
2010-02-24
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
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-086-30Carbamazepine30 in 1 BLISTER PACKTABLET301
67046-086-60Carbamazepine60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-086CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20100226_8e06995c-26c9-4ef3-9421-16a2360db628.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN8e06995c-26c9-4ef3-9421-16a2360db6281
308979carbamazepine 200 MG Oral TabletSCD8e06995c-26c9-4ef3-9421-16a2360db6281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-086-306704600863030 in 1 BLISTER PACKHistorical
67046-086-606704600866060 in 1 BLISTER PACKHistorical