OXCARBAZEPINE

Product NDC
60429-061
11-digit product format
604290061
Labeler code
60429
Product ID
60429-061_45b3173c-282f-9856-e063-6394a90abdf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
Substance
OXCARBAZEPINE
Active strength
150 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136, 312137, 312138

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-061-01OXCARBAZEPINE100 in 1 BOTTLETABLET, FILM COATED10018
60429-061-05OXCARBAZEPINE500 in 1 BOTTLETABLET, FILM COATED50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-061-05EA - Each60429-0612ec9aaf5-eca5-44fd-aafa-0eb56ef91fd912019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-061OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]17Current NDC, Legacy NDC, 2 package rows20240124_b9db5c45-8b51-449b-b4af-1a235c08f189.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb9db5c45-8b51-449b-b4af-1a235c08f18918
312137OXcarbazepine 300 MG Oral TabletPSNb9db5c45-8b51-449b-b4af-1a235c08f18918
312138OXcarbazepine 600 MG Oral TabletPSNb9db5c45-8b51-449b-b4af-1a235c08f18918
312136oxcarbazepine 150 MG Oral TabletSCDb9db5c45-8b51-449b-b4af-1a235c08f18918
312137oxcarbazepine 300 MG Oral TabletSCDb9db5c45-8b51-449b-b4af-1a235c08f18918
312138oxcarbazepine 600 MG Oral TabletSCDb9db5c45-8b51-449b-b4af-1a235c08f18918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-061-0160429006101100 TABLET, FILM COATED in 1 BOTTLE (60429-061-01) 2013-04-110000-00-00NoNoCurrent
60429-061-0560429006105500 TABLET, FILM COATED in 1 BOTTLE (60429-061-05) 2019-09-100000-00-00NoNoCurrent