FDA.reportPublic FDA data

Carbamazepine

Product NDC
72664-218
11-digit product format
726640218
Labeler code
72664
Product ID
72664-218_ca8bfc0a-d43b-1072-e053-2995a90a66f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
VGYAAN Pharmaceuticals LLC
Application
ANDA214328
Marketing category
ANDA
Marketing start
2022-01-03
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
No
Listing certified through
2022-12-31
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
72664-218-012026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only
72664-218-102026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only
72664-218-302026-01-29C16284748780-149896155-aba7-586f-e063-e6dba90add90Carbamazepine Tablets USP, 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72664-218-01Carbamazepine100 in 1 BOTTLETABLET1006
72664-218-10Carbamazepine1000 in 1 BOTTLETABLET10006
72664-218-30Carbamazepine30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72664-218CARBAMAZEPINE TABLET [VGYAAN PHARMACEUTICALS LLC]6Legacy NDC, 3 package rows20230923_6626654b-6af4-4fc0-83df-08d6438a6beb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN6626654b-6af4-4fc0-83df-08d6438a6beb6
308979carbamazepine 200 MG Oral TabletSCD6626654b-6af4-4fc0-83df-08d6438a6beb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72664-218-0172664021801100 TABLET in 1 BOTTLE (72664-218-01) 100 tablet2022-01-030000-00-00NoNoCurrent
72664-218-10726640218101000 TABLET in 1 BOTTLE (72664-218-10) 1000 tablet2022-01-030000-00-00NoNoCurrent
72664-218-307266402183030 TABLET in 1 BOTTLE (72664-218-30) 30 tablet2022-01-030000-00-00NoNoCurrent