FDA.reportPublic FDA data

Carbamazepine

Product NDC
68788-9812
11-digit product format
687889812
Labeler code
68788
Product ID
68788-9812_b387be7e-e619-46b5-a7cc-2fcc0484e30a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA075687
Marketing category
ANDA
Marketing start
2012-04-23
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-9812-12019-11-27C16284748780-19855e2a2-4cbc-60a7-e053-dbdaa90a05bdCarbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-22019-11-27C16284748780-19855e2a2-4cbc-60a7-e053-dbdaa90a05bdCarbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-32019-11-27C16284748780-19855e2a2-4cbc-60a7-e053-dbdaa90a05bdCarbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-62019-11-27C16284748780-19855e2a2-4cbc-60a7-e053-dbdaa90a05bdCarbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-92019-11-27C16284748780-19855e2a2-4cbc-60a7-e053-dbdaa90a05bdCarbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9812-1Carbamazepine100 in 1 BOTTLETABLET, CHEWABLE1003
68788-9812-2Carbamazepine20 in 1 BOTTLETABLET, CHEWABLE203
68788-9812-3Carbamazepine30 in 1 BOTTLETABLET, CHEWABLE303
68788-9812-6Carbamazepine60 in 1 BOTTLETABLET, CHEWABLE603
68788-9812-9Carbamazepine90 in 1 BOTTLETABLET, CHEWABLE903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbamazepineACTIVE INGREDIENT33CM23913MCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
CarbamazepineACTIVE MOIETY33CM23913MCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
aluminum oxideINACTIVE INGREDIENTLMI26O6933CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
diethyl phthalateINACTIVE INGREDIENTUF064M00AFCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
sorbitolINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3
starch, cornINACTIVE INGREDIENTO8232NY3SJCARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9812CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]3Legacy NDC, 5 package rows20140402_157f67bd-74f0-4d68-9058-8fa707c564be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197442carBAMazepine 200 MG Chewable TabletPSN157f67bd-74f0-4d68-9058-8fa707c564be3
197442carbamazepine 200 MG Chewable TabletSCD157f67bd-74f0-4d68-9058-8fa707c564be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9812-168788981201100 in 1 BOTTLEHistorical
68788-9812-26878898120220 in 1 BOTTLEHistorical
68788-9812-36878898120330 in 1 BOTTLEHistorical
68788-9812-66878898120660 in 1 BOTTLEHistorical
68788-9812-96878898120990 in 1 BOTTLEHistorical