FDA.reportPublic FDA data

CARBAMAZEPINE

Product NDC
50090-2161
11-digit product format
500902161
Labeler code
50090
Product ID
50090-2161_5c28bb65-9313-40e2-9630-cd3302dd3f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075948
Marketing category
ANDA
Marketing start
2002-09-01
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
2021-12-31
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
50090-2161-02023-01-30C16284748780-1f386c649-df7a-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS, USP 200 mg
50090-2161-12023-01-30C16284748780-1f386c649-df7a-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS, USP 200 mg
50090-2161-32023-01-30C16284748780-1f386c649-df7a-0266-e053-dadaa90a7c1aCARBAMAZEPINE TABLETS, USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2161-0CARBAMAZEPINE100 in 1 BOTTLETABLET1008
50090-2161-1CARBAMAZEPINE60 in 1 BOTTLETABLET608
50090-2161-3CARBAMAZEPINE28 in 1 BOTTLETABLET288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2161-0EA - Each50090-2161c16d3e8d-a081-4c50-b6e0-5563d2899a3612019-02-13
50090-2161-1EA - Each50090-216171abd89f-ae36-44c3-905d-fc2e2e89c49e12019-02-13
50090-2161-3EA - Each50090-2161a7e77d2f-b954-454f-aae6-dc7cd466f32312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2161CARBAMAZEPINE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 3 package rows20200121_3554a0b6-ea96-4516-81d7-cc2d27b4fc33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN3554a0b6-ea96-4516-81d7-cc2d27b4fc338
308979carbamazepine 200 MG Oral TabletSCD3554a0b6-ea96-4516-81d7-cc2d27b4fc338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2161-050090216100100 TABLET in 1 BOTTLE (50090-2161-0) 100 tablet2015-10-210000-00-00NoNoCurrent
50090-2161-15009021610160 in 1 BOTTLEHistorical
50090-2161-35009021610328 TABLET in 1 BOTTLE (50090-2161-3) 28 tablet2015-10-210000-00-00NoNoCurrent