FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
69452-125
11-digit product format
694520125
Labeler code
69452
Product ID
69452-125_44eb29ac-e607-a84a-e063-6394a90a9e72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209652
Marketing category
ANDA
Marketing start
2023-02-14
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
69452-125-50Oxcarbazepine250 mL in 1 BOTTLE, GLASSSUSPENSION2509
69452-125-50Oxcarbazepine1 in 1 CARTONSUSPENSION19
69452-125-51Oxcarbazepine1 in 1 CARTONSUSPENSION19
69452-125-51Oxcarbazepine250 mL in 1 BOTTLE, PLASTICSUSPENSION2509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-125-50ML - Milliliter69452-1254fe21ab9-18b7-496b-80a0-79263c2297ed12023-04-07
69452-125-51ML - Milliliter69452-125426716d0-e8af-4f0a-8aed-fd2c215047b312026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-125OXCARBAZEPINE SUSPENSION [BIONPHARMA INC.]8Current NDC, 4 package rows20250308_ec033897-21b4-4d08-83de-042783e89251.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSNec033897-21b4-4d08-83de-042783e892519
283536oxcarbazepine 60 MG/ML Oral SuspensionSCDec033897-21b4-4d08-83de-042783e892519
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSYec033897-21b4-4d08-83de-042783e892519
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN19b0945c-92a4-3cfe-e063-6294a90a4b282
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD19b0945c-92a4-3cfe-e063-6294a90a4b282
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY19b0945c-92a4-3cfe-e063-6294a90a4b282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-125-50694520125501 BOTTLE, GLASS in 1 CARTON (69452-125-50) / 250 mL in 1 BOTTLE, GLASS2023-02-14NoNoHistorical
69452-125-51694520125511 BOTTLE, PLASTIC in 1 CARTON (69452-125-51) / 250 mL in 1 BOTTLE, PLASTIC2025-12-01NoNoHistorical