Oxcarbazepine

Product NDC
85742-007
11-digit product format
857420007
Labeler code
85742
Product ID
85742-007_67f2f09b-b51c-42fe-aa1a-3bf360c5d348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kanchan Healthcare Inc
Application
ANDA217782
Marketing category
ANDA
Marketing start
2025-05-01
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85742-007-06Oxcarbazepine250 mL in 1 BOTTLE, GLASSSUSPENSION2504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85742-007-06ML - Milliliter85742-0072788faab-6f3a-4710-8fbd-3f27ad63d0bd12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN87f53c04-075c-4d09-925a-0faeaa14f3f9100
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD87f53c04-075c-4d09-925a-0faeaa14f3f9100
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY87f53c04-075c-4d09-925a-0faeaa14f3f9100
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN7be73d22-f87b-4459-a91c-37c1e34db2304
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD7be73d22-f87b-4459-a91c-37c1e34db2304
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY7be73d22-f87b-4459-a91c-37c1e34db2304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85742-007-0685742000706250 mL in 1 BOTTLE, GLASS (85742-007-06) 250 ml2025-05-01NoNoHistorical