FDA.reportPublic FDA data

Carbamazepine

Product NDC
66993-409
11-digit product format
669930409
Labeler code
66993
Product ID
66993-409_711ea8fa-f21f-442f-9e10-2b0aa78ae8cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA020712
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-12-15
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
300 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-409-32EA - Each66993-40907954edb-1948-498b-98eb-574db7124b8812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]4
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-409CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]14Legacy NDC20230609_7a1e523a-b377-43dc-b231-7591c4c888ea.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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-409-3266993040932120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-409-32) 2011-12-150000-00-00NoNoCurrent