Oxcarbazepine

Product NDC
63304-653
11-digit product format
633040653
Labeler code
63304
Product ID
63304-653_5989f59b-7495-45ed-a245-1e404264175e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA078734
Marketing category
ANDA
Marketing start
2009-12-14
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
60 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-653-25Oxcarbazepine250 mL in 1 BOTTLESUSPENSION2508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-653-25ML - Milliliter63304-65367010cc1-d1c5-4a7f-8f8a-27de16d84ea112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0ROXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5EOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BOXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
SORBITOLINACTIVE INGREDIENT506T60A25ROXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0ROXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-653OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]8Legacy NDC, 1 package rows20150217_ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSNca6bfbbb-fcca-4c15-a160-ee5791ed2f6e8
283536oxcarbazepine 60 MG/ML Oral SuspensionSCDca6bfbbb-fcca-4c15-a160-ee5791ed2f6e8
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSYca6bfbbb-fcca-4c15-a160-ee5791ed2f6e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63304-653-2563304065325250 mL in 1 BOTTLE250 mlHistorical