FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
70518-3197
Requested package NDC
70518-3197-0
11-digit product format
705183197
Labeler code
70518
Product ID
70518-3197_4ece29f3-241b-21d8-e063-6394a90aa62a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077802
Marketing category
ANDA
Marketing start
2021-08-18
Substance
OXCARBAZEPINE
Active strength
600 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-319770518-3197-0DDiscontinued by firm2026-07-31

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
ndc (package): 70518-3197-0
ndc (product): 70518-3197
ndc11 (package): 70518319700
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

Additional Listing Data#

Finished product
Yes
Brand name base
Oxcarbazepine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VZI5B1W380Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312138Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a90cd1f1-5258-4b0e-92fd-c4cebe47772bAvailable on FDA.report

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
70518-3197-02023-03-21C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-02023-03-21C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-12023-03-21C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-12023-03-21C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-02023-01-30C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-02023-01-30C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-12023-01-30C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
70518-3197-12023-01-30C16284748780-1f386c649-99de-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3197-0Oxcarbazepine30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3197-1Oxcarbazepine100 in 1 BOXTABLET, FILM COATED1009
70518-3197-2Oxcarbazepine1 in 1 POUCHTABLET, FILM COATED19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSNa90cd1f1-5258-4b0e-92fd-c4cebe47772b9
312138oxcarbazepine 600 MG Oral TabletSCDa90cd1f1-5258-4b0e-92fd-c4cebe47772b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3197-07051831970030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3197-0) 2021-08-180000-00-00NoNoCurrent