Carbamazepine

Product NDC
69189-0410
11-digit product format
691890410
Labeler code
69189
Product ID
69189-0410_0d939182-203f-4414-b3f2-4ad3fac8440e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA020712
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-06-08
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
300 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-0410-12020-01-31C16284748780-19d75b9d1-2607-f424-e053-dadaa90a57ceCarbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-0410-1Carbamazepine1 in 1 DOSE PACKCAPSULE, EXTENDED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-0410CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20160302_de6b0fd5-11fe-4f19-90e6-54339be5c9fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNde6b0fd5-11fe-4f19-90e6-54339be5c9fc1
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDde6b0fd5-11fe-4f19-90e6-54339be5c9fc1
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYde6b0fd5-11fe-4f19-90e6-54339be5c9fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-0410-1691890410011 in 1 DOSE PACKHistorical