FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
65162-649
11-digit product format
651620649
Labeler code
65162
Product ID
65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202961
Marketing category
ANDA
Marketing start
2012-06-04
Substance
OXCARBAZEPINE
Active strength
300 mg/5mL
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
OXCARBAZEPINE300 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui283536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-649-43Oxcarbazepine5 mL in 1 CUP, UNIT-DOSESUSPENSION528
65162-649-48Oxcarbazepine10 in 1 TRAYSUSPENSION1028
65162-649-78Oxcarbazepine1 in 1 CARTONSUSPENSION128
65162-649-78Oxcarbazepine250 mL in 1 BOTTLESUSPENSION25028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-649-78ML - Milliliter65162-6491f057bcc-6f00-46a9-b8a1-aa70e9418d4712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SORBITOLINACTIVE INGREDIENT506T60A25ROXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
WATERINACTIVE INGREDIENT059QF0KO0ROXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-649OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS LLC]27Current NDC, Legacy NDC, 4 package rows20250227_2515391e-3a88-4226-92e5-f641c8409fe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN148b90ba-236a-47cc-b171-22dd7f8f8e0a102
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD148b90ba-236a-47cc-b171-22dd7f8f8e0a102
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY148b90ba-236a-47cc-b171-22dd7f8f8e0a102
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN2515391e-3a88-4226-92e5-f641c8409fe528
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD2515391e-3a88-4226-92e5-f641c8409fe528
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY2515391e-3a88-4226-92e5-f641c8409fe528
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN636fc847-b3d2-4255-a959-d75499fdb1983
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD636fc847-b3d2-4255-a959-d75499fdb1983
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY636fc847-b3d2-4255-a959-d75499fdb1983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-649-43651620649435 mL in 1 CUP, UNIT-DOSE5 mlHistorical
65162-649-486516206494810 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43) 2012-06-040000-00-00NoNoCurrent
65162-649-78651620649781 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE1 bottle2012-06-040000-00-00NoNoCurrent