FDA.reportPublic FDA data

Epitol

Product NDC
0093-0090
11-digit product format
000930090
Labeler code
0093
Product ID
0093-0090_5c31da75-fc21-4ab2-9487-64169767ebd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA070541
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Epitol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui211817, 308979

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
0093-0090-01Epitol100 in 1 BOTTLETABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0090-01EA - Each0093-0090690d4abb-c43f-4123-8c3f-1c3b1e102e7812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MEPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
CARBAMAZEPINEACTIVE MOIETY33CM23913MEPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
ETHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVEPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0090EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA, INC.]17Current NDC, Legacy NDC, 1 package rows20240331_32bbe864-7374-44da-8c6e-e733f0648243.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN32bbe864-7374-44da-8c6e-e733f064824318
211817Epitol 200 MG Oral TabletPSN32bbe864-7374-44da-8c6e-e733f064824318
211817carbamazepine 200 MG Oral Tablet [Epitol]SBD32bbe864-7374-44da-8c6e-e733f064824318
308979carbamazepine 200 MG Oral TabletSCD32bbe864-7374-44da-8c6e-e733f064824318
211817Epitol 200 MG Oral TabletSY32bbe864-7374-44da-8c6e-e733f064824318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0090-0100093009001100 TABLET in 1 BOTTLE (0093-0090-01) 100 tablet1990-09-302026-07-31NoNoCurrent