FDA.reportPublic FDA data

Carbamazepine

Product NDC
51407-895
11-digit product format
514070895
Labeler code
51407
Product ID
51407-895_4b219175-e01f-8e98-e063-6294a90a12e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078115
Marketing category
ANDA
Marketing start
2009-03-31
Substance
CARBAMAZEPINE
Active strength
100 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui199378, 402505, 402506

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-895-01Carbamazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-895-01EA - Each51407-895935989d5-e68b-4ffb-9d33-1d07035b55f912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-895CARBAMAZEPINE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 1 package rows20250119_1922a7cd-6a43-dab5-e063-6294a90a3d8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199378carBAMazepine 100 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402505carBAMazepine 200 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402506carBAMazepine 400 MG 12HR Extended Release Oral TabletPSN1922a7cd-6a43-dab5-e063-6294a90a3d8f4
19937812 HR carbamazepine 100 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
40250512 HR carbamazepine 200 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
40250612 HR carbamazepine 400 MG Extended Release Oral TabletSCD1922a7cd-6a43-dab5-e063-6294a90a3d8f4
199378carbamazepine 100 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402505carbamazepine 200 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4
402506carbamazepine 400 MG 12 HR Extended Release Oral TabletSY1922a7cd-6a43-dab5-e063-6294a90a3d8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-895-0151407089501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-895-01) 2024-03-20NoNoHistorical