CARBAMAZEPINE

Product NDC
67046-096
11-digit product format
670460096
Labeler code
67046
Product ID
67046-096_5940711d-71a8-cb7d-e053-2a91aa0aef18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077272
Marketing category
ANDA
Marketing start
2009-10-23
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
No
Listing certified through
2020-12-31
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
67046-096-302022-01-28C16284748780-1d6a99b39-4e7b-a426-e053-dadaa90af4c2Carbamazepine Tablets, USP 200 mg 096

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-096-30CARBAMAZEPINE30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-096CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170918_5940711d-71a7-cb7d-e053-2a91aa0aef18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN5940711d-71a7-cb7d-e053-2a91aa0aef181
308979carbamazepine 200 MG Oral TabletSCD5940711d-71a7-cb7d-e053-2a91aa0aef181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-096-306704600963030 TABLET in 1 BLISTER PACK (67046-096-30) 30 tablet2017-09-180000-00-00NoNoCurrent