FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
21695-862
11-digit product format
216950862
Labeler code
21695
Product ID
21695-862_e8a485af-a78b-49a0-9bf4-75e1cd5bb740
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077802
Marketing category
ANDA
Marketing start
2007-10-09
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
150 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-862IInactivated by FDA2026-07-31
excluded packagepackage21695-86221695-862-30IInactivated by FDA2026-07-31
excluded packagepackage21695-86221695-862-60IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077802-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2007-10-09
A077802-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2007-10-09
A077802-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2007-10-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077802-001AB
A077802-002AB
A077802-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077802-001OXCARBAZEPINE150MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-002OXCARBAZEPINE300MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-003OXCARBAZEPINE600MGTABLET / ORALAB2007-10-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077802-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxcarbazepineOXCARBAZEPINECoupler LLC51008af2-39ac-546c-e063-6294a90a758f2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINECoupler LLC50873ef7-3deb-7386-e063-6394a90a9c192026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a90cd1f1-5258-4b0e-92fd-c4cebe47772b2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a2032bcc-2da5-45e5-aa3f-ddbf50909df82026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEGlenmark Pharmaceuticals Inc., USA1c713b59-a628-42e6-b166-ae71c39132842025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEDirect_rx21b0cc84-b64a-75de-e063-6294a90a9dd02024-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEProficient Rx LP95867dcd-fd0e-4570-987b-d35939f7d7d12022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-862-302019-09-24C16284748780-1934fe258-4905-48b1-e053-8cdaa90a720aOxcarbazepine Tablets
21695-862-602019-09-24C16284748780-1934fe258-4905-48b1-e053-8cdaa90a720aOxcarbazepine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-862-30Oxcarbazepine30 in 1 BOTTLETABLET, FILM COATED301
21695-862-60Oxcarbazepine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-862-30EA - Each21695-862036c597f-5a8e-4f4a-aa4b-059ac2c86c6512012-07-24
21695-862-60EA - Each21695-86242fd2351-5539-4fb7-87ca-6889bba1d82d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-862OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20111021_e8a485af-a78b-49a0-9bf4-75e1cd5bb740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNe8a485af-a78b-49a0-9bf4-75e1cd5bb7401
312137OXcarbazepine 300 MG Oral TabletPSNe8a485af-a78b-49a0-9bf4-75e1cd5bb7401
312138OXcarbazepine 600 MG Oral TabletPSNe8a485af-a78b-49a0-9bf4-75e1cd5bb7401
312136oxcarbazepine 150 MG Oral TabletSCDe8a485af-a78b-49a0-9bf4-75e1cd5bb7401
312137oxcarbazepine 300 MG Oral TabletSCDe8a485af-a78b-49a0-9bf4-75e1cd5bb7401
312138oxcarbazepine 600 MG Oral TabletSCDe8a485af-a78b-49a0-9bf4-75e1cd5bb7401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-862-302169508623030 in 1 BOTTLEHistorical
21695-862-602169508626060 in 1 BOTTLEHistorical