FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
51991-054
11-digit product format
519910054
Labeler code
51991
Product ID
51991-054_90534569-92c7-40dd-a902-60e36d3d936c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
Substance
OXCARBAZEPINE
Active strength
300 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
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136, 312137, 312138

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
51991-054-01OXCARBAZEPINE100 in 1 BOTTLETABLET, FILM COATED1005
51991-054-05OXCARBAZEPINE500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-054-01EA - Each51991-054e2a53ae8-68ac-4173-bb52-e369cfca54ff12025-08-11
51991-054-05EA - Each51991-05451b360d6-8c06-415c-bac4-ee211abc88b612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-054OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]1Current NDC, 2 package rows20250209_54fb494e-bce4-442d-954a-757f9851e81e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN54fb494e-bce4-442d-954a-757f9851e81e5
312137OXcarbazepine 300 MG Oral TabletPSN54fb494e-bce4-442d-954a-757f9851e81e5
312138OXcarbazepine 600 MG Oral TabletPSN54fb494e-bce4-442d-954a-757f9851e81e5
312136oxcarbazepine 150 MG Oral TabletSCD54fb494e-bce4-442d-954a-757f9851e81e5
312137oxcarbazepine 300 MG Oral TabletSCD54fb494e-bce4-442d-954a-757f9851e81e5
312138oxcarbazepine 600 MG Oral TabletSCD54fb494e-bce4-442d-954a-757f9851e81e5
312136OXcarbazepine 150 MG Oral TabletPSN567c0777-9bc5-45a9-ba25-959dd76d0e052
312137OXcarbazepine 300 MG Oral TabletPSN567c0777-9bc5-45a9-ba25-959dd76d0e052
312138OXcarbazepine 600 MG Oral TabletPSN567c0777-9bc5-45a9-ba25-959dd76d0e052
312136oxcarbazepine 150 MG Oral TabletSCD567c0777-9bc5-45a9-ba25-959dd76d0e052
312137oxcarbazepine 300 MG Oral TabletSCD567c0777-9bc5-45a9-ba25-959dd76d0e052
312138oxcarbazepine 600 MG Oral TabletSCD567c0777-9bc5-45a9-ba25-959dd76d0e052
312137OXcarbazepine 300 MG Oral TabletPSNfcf5044a-8cfd-47d5-9f47-8f6674843c241
312137oxcarbazepine 300 MG Oral TabletSCDfcf5044a-8cfd-47d5-9f47-8f6674843c241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51991-054-0151991005401100 TABLET, FILM COATED in 1 BOTTLE (51991-054-01) 2025-01-29NoNoHistorical
51991-054-0551991005405500 TABLET, FILM COATED in 1 BOTTLE (51991-054-05) 2025-01-29NoNoHistorical