OXCARBAZEPINE

Product NDC
51672-1393
11-digit product format
516721393
Labeler code
51672
Product ID
51672-1393_440646d8-f538-5968-e063-6394a90ab7cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078734
Marketing category
ANDA
Marketing start
2025-08-06
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
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
OXCARBAZEPINE60 mg/mL

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1393-1OXCARBAZEPINE1 in 1 CARTONSUSPENSION18
51672-1393-1OXCARBAZEPINE250 mL in 1 BOTTLE, GLASSSUSPENSION2508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1393OXCARBAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, 2 package rows20250125_9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c8
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c8
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51672-1393-1516721393011 BOTTLE, GLASS in 1 CARTON (51672-1393-1) / 250 mL in 1 BOTTLE, GLASS2025-08-06NoNoHistorical