FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
62756-185
11-digit product format
627560185
Labeler code
62756
Product ID
62756-185_56aeed00-02fa-483d-b4be-45362e10f5ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077794
Marketing category
ANDA
Marketing start
2007-10-09
Substance
OXCARBAZEPINE
Active strength
600 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380

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
62756-185-08Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED10021
62756-185-13Oxcarbazepine500 in 1 BOTTLETABLET, FILM COATED50021
62756-185-18Oxcarbazepine1000 in 1 BOTTLETABLET, FILM COATED100021
62756-185-83Oxcarbazepine30 in 1 BOTTLETABLET, FILM COATED3021
62756-185-88Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-185-13EA - Each62756-185885334dc-ce0b-4eb3-9174-bc525709c27012012-07-24
62756-185-18EA - Each62756-185c1ab62d3-7bf3-42c4-9e8a-613c134f1dc412012-07-24
62756-185-88EA - Each62756-185184ae2f5-4e86-417b-81af-1790139e60af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-185OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 5 package rows20241112_7ecd5eef-46f4-407f-9b63-ba65adb3eced.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312137OXcarbazepine 300 MG Oral TabletPSN7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312138OXcarbazepine 600 MG Oral TabletPSN7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312136oxcarbazepine 150 MG Oral TabletSCD7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312137oxcarbazepine 300 MG Oral TabletSCD7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312138oxcarbazepine 600 MG Oral TabletSCD7ecd5eef-46f4-407f-9b63-ba65adb3eced21
312136OXcarbazepine 150 MG Oral TabletPSNabbf6b75-bc22-42af-ae08-445d8c1860921
312137OXcarbazepine 300 MG Oral TabletPSNabbf6b75-bc22-42af-ae08-445d8c1860921
312138OXcarbazepine 600 MG Oral TabletPSNabbf6b75-bc22-42af-ae08-445d8c1860921
312136oxcarbazepine 150 MG Oral TabletSCDabbf6b75-bc22-42af-ae08-445d8c1860921
312137oxcarbazepine 300 MG Oral TabletSCDabbf6b75-bc22-42af-ae08-445d8c1860921
312138oxcarbazepine 600 MG Oral TabletSCDabbf6b75-bc22-42af-ae08-445d8c1860921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-185-0862756018508100 TABLET, FILM COATED in 1 BOTTLE (62756-185-08) 2007-10-090000-00-00NoNoCurrent
62756-185-1362756018513500 TABLET, FILM COATED in 1 BOTTLE (62756-185-13) 2007-10-090000-00-00NoNoCurrent
62756-185-18627560185181000 TABLET, FILM COATED in 1 BOTTLE (62756-185-18) 2007-10-090000-00-00NoNoCurrent
62756-185-836275601858330 TABLET, FILM COATED in 1 BOTTLE (62756-185-83) 2007-10-090000-00-00NoNoCurrent
62756-185-8862756018588100 TABLET, FILM COATED in 1 BOTTLE (62756-185-88) 2007-10-090000-00-00NoNoCurrent