FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
51991-053
11-digit product format
519910053
Labeler code
51991
Product ID
51991-053_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
150 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
OXCARBAZEPINE150 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
51991-053-01OXCARBAZEPINE100 in 1 BOTTLETABLET, FILM COATED1005
51991-053-05OXCARBAZEPINE500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-053-01EA - Each51991-0538cd735a0-933d-4fe1-8a49-f7af29ef8a4812025-08-11
51991-053-05EA - Each51991-05357a43d00-077b-49a1-a29a-a44f6afc3d7912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-053OXCARBAZEPINE 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
312136OXcarbazepine 150 MG Oral TabletPSNa1b6a698-f7d9-4adb-9e38-b63e7a85e2b32
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
312136oxcarbazepine 150 MG Oral TabletSCDa1b6a698-f7d9-4adb-9e38-b63e7a85e2b32
312137oxcarbazepine 300 MG Oral TabletSCD567c0777-9bc5-45a9-ba25-959dd76d0e052
312138oxcarbazepine 600 MG Oral TabletSCD567c0777-9bc5-45a9-ba25-959dd76d0e052
312136OXcarbazepine 150 MG Oral TabletPSN3f15c889-4386-850b-e063-6294a90a8dbf1
312136oxcarbazepine 150 MG Oral TabletSCD3f15c889-4386-850b-e063-6294a90a8dbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51991-053-0151991005301100 TABLET, FILM COATED in 1 BOTTLE (51991-053-01) 2025-01-29NoNoHistorical
51991-053-0551991005305500 TABLET, FILM COATED in 1 BOTTLE (51991-053-05) 2025-01-29NoNoHistorical