CARBAMAZEPINE

Product NDC
60432-129
11-digit product format
604320129
Labeler code
60432
Product ID
60432-129_187523ab-0aff-4b96-9677-b3909a620213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA075714
Marketing category
ANDA
Marketing start
2002-06-05
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/5mL
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-129-162025-11-17C16284748780-1f386c649-e067-0266-e053-dadaa90a7c1a99e20867-a5eb-4474-b846-619ee45f40b8
60432-129-162023-01-30C16284748780-1f386c649-e067-0266-e053-dadaa90a7c1a99e20867-a5eb-4474-b846-619ee45f40b8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-129-16ML - Milliliter60432-129df921e6d-f573-4d05-ac79-b8acc5202fbc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbamazepineACTIVE INGREDIENT33CM23913MCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
CarbamazepineACTIVE MOIETY33CM23913MCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
SorbitolINACTIVE INGREDIENT506T60A25RCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
SucroseINACTIVE INGREDIENTC151H8M554CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
VanillinINACTIVE INGREDIENTCHI530446XCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
WaterINACTIVE INGREDIENT059QF0KO0RCARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9
Xanthan GumINACTIVE INGREDIENTTTV12P4NEECARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-129CARBAMAZEPINE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]14Legacy NDC20181222_99e20867-a5eb-4474-b846-619ee45f40b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 20 MG/ML Oral SuspensionSCD364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-129-1660432012916450 mL in 1 BOTTLE, PLASTIC (60432-129-16) 450 ml2002-06-050000-00-00NoNoCurrent