CARBAMAZEPINE

Product NDC
68788-7210
11-digit product format
687887210
Labeler code
68788
Product ID
68788-7210_fc6363d3-830f-49b8-8aea-e34f47ead0d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075948
Marketing category
ANDA
Marketing start
2018-08-06
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
68788-7210-1CARBAMAZEPINE100 in 1 BOTTLETABLET1009
68788-7210-2CARBAMAZEPINE20 in 1 BOTTLETABLET209
68788-7210-3CARBAMAZEPINE30 in 1 BOTTLETABLET309
68788-7210-6CARBAMAZEPINE60 in 1 BOTTLETABLET609
68788-7210-8CARBAMAZEPINE28 in 1 BOTTLETABLET289
68788-7210-9CARBAMAZEPINE90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7210CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 6 package rows20250215_32dc301e-881d-47b0-ad16-f9ff31d19324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN32dc301e-881d-47b0-ad16-f9ff31d193249
308979carbamazepine 200 MG Oral TabletSCD32dc301e-881d-47b0-ad16-f9ff31d193249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7210-168788721001100 TABLET in 1 BOTTLE (68788-7210-1) 100 tablet2018-08-060000-00-00NoNoCurrent
68788-7210-26878872100220 TABLET in 1 BOTTLE (68788-7210-2) 20 tablet2018-08-060000-00-00NoNoCurrent
68788-7210-36878872100330 TABLET in 1 BOTTLE (68788-7210-3) 30 tablet2018-08-060000-00-00NoNoCurrent
68788-7210-66878872100660 TABLET in 1 BOTTLE (68788-7210-6) 60 tablet2018-08-060000-00-00NoNoCurrent
68788-7210-86878872100828 TABLET in 1 BOTTLE (68788-7210-8) 28 tablet2018-08-060000-00-00NoNoCurrent
68788-7210-96878872100990 TABLET in 1 BOTTLE (68788-7210-9) 90 tablet2018-08-060000-00-00NoNoCurrent