FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
27241-239
11-digit product format
272410239
Labeler code
27241
Product ID
27241-239_ffbd0c62-0cbd-4ea3-b1a1-1a40a16884e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA217659
Marketing category
ANDA
Marketing start
2024-02-22
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
2027-12-31
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
Rxcui1365653, 1365842, 1365844

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
27241-239-01Oxcarbazepine100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-239-01EA - Each27241-239017ebad9-5da8-4796-b71b-652e76eb556012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-239OXCARBAZEPINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]3Current NDC, 1 package rows20240915_d947e9b1-2a15-4048-bb4e-fe56b6851848.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365653OXcarbazepine 150 MG 24HR Extended Release Oral TabletPSNd947e9b1-2a15-4048-bb4e-fe56b68518484
1365842OXcarbazepine 300 MG 24HR Extended Release Oral TabletPSNd947e9b1-2a15-4048-bb4e-fe56b68518484
1365844OXcarbazepine 600 MG 24HR Extended Release Oral TabletPSNd947e9b1-2a15-4048-bb4e-fe56b68518484
136565324 HR oxcarbazepine 150 MG Extended Release Oral TabletSCDd947e9b1-2a15-4048-bb4e-fe56b68518484
136584224 HR oxcarbazepine 300 MG Extended Release Oral TabletSCDd947e9b1-2a15-4048-bb4e-fe56b68518484
136584424 HR oxcarbazepine 600 MG Extended Release Oral TabletSCDd947e9b1-2a15-4048-bb4e-fe56b68518484
1365653oxcarbazepine 150 MG 24 HR Extended Release Oral TabletSYd947e9b1-2a15-4048-bb4e-fe56b68518484
1365842oxcarbazepine 300 MG 24 HR Extended Release Oral TabletSYd947e9b1-2a15-4048-bb4e-fe56b68518484
1365844oxcarbazepine 600 MG 24 HR Extended Release Oral TabletSYd947e9b1-2a15-4048-bb4e-fe56b68518484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-239-0127241023901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-239-01) 2024-02-22NoNoCurrent