Carbamazepine

Product NDC
50090-5740
11-digit product format
500905740
Labeler code
50090
Product ID
50090-5740_a420fd55-7029-4cc4-b63e-12fdcb76e6fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207798
Marketing category
ANDA
Marketing start
2020-04-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbamazepine
Listing expiration
2026-12-31

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
50090-5740-0Carbamazepine100 in 1 BOTTLETABLET1007
50090-5740-3Carbamazepine28 in 1 BOTTLETABLET287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5740-0EA - Each50090-5740c37cfa3d-37bd-44bb-860a-21bb6e8c8c2512022-08-04
50090-5740-3EA - Each50090-57407f33637a-dfb3-4e0e-a7fe-18b9b77095d012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5740CARBAMAZEPINE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20250221_047bc284-060a-4db9-bf37-75d10f95a0a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN047bc284-060a-4db9-bf37-75d10f95a0a67
308979carbamazepine 200 MG Oral TabletSCD047bc284-060a-4db9-bf37-75d10f95a0a67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5740-050090574000100 TABLET in 1 BOTTLE (50090-5740-0) 100 tablet2021-09-290000-00-00NoNoCurrent
50090-5740-35009057400328 TABLET in 1 BOTTLE (50090-5740-3) 28 tablet2021-09-290000-00-00NoNoCurrent