FDA.reportPublic FDA data

Carbamazepine

Product NDC
51407-215
11-digit product format
514070215
Labeler code
51407
Product ID
51407-215_4aa97817-1330-a973-e063-6394a90a5ccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074649
Marketing category
ANDA
Marketing start
1996-10-03
Substance
CARBAMAZEPINE
Active strength
200 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
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui308979

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
51407-215-01Carbamazepine100 in 1 BOTTLETABLET1008
51407-215-10Carbamazepine1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-215-01EA - Each51407-2158c707983-de24-45ad-b17a-756fd14f34f812019-09-05
51407-215-10EA - Each51407-21533bd1708-a489-4415-8c3d-7b935c83b5b612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-215CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 2 package rows20250119_8a1ce79d-18ea-f30b-e053-2995a90ad1fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN8a1ce79d-18ea-f30b-e053-2995a90ad1fb8
308979carbamazepine 200 MG Oral TabletSCD8a1ce79d-18ea-f30b-e053-2995a90ad1fb8
308979carBAMazepine 200 MG Oral TabletPSN41720bf1-61cb-4bc6-ac53-bda416af15fc1
308979carBAMazepine 200 MG Oral TabletPSN697f3e5a-c84b-44a6-b9f3-15e7d9bb63951
308979carbamazepine 200 MG Oral TabletSCD41720bf1-61cb-4bc6-ac53-bda416af15fc1
308979carbamazepine 200 MG Oral TabletSCD697f3e5a-c84b-44a6-b9f3-15e7d9bb63951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-215-0151407021501100 TABLET in 1 BOTTLE (51407-215-01) 100 tablet2019-05-090000-00-00NoNoCurrent
51407-215-10514070215101000 TABLET in 1 BOTTLE (51407-215-10) 1000 tablet2019-05-090000-00-00NoNoCurrent