OXCARBAZEPINE

Product NDC
0904-7263
11-digit product format
009047263
Labeler code
0904
Product ID
0904-7263_55b0fa69-7b11-49df-972a-e1d39b35b322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078069
Marketing category
ANDA
Marketing start
2022-11-07
Marketing end
2027-08-31
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
2026-12-31
Current FDA listing
Yes

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
A078069-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2008-01-11
A078069-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2008-01-11
A078069-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2008-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078069-001AB
A078069-002AB
A078069-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-002OXCARBAZEPINE300MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-003OXCARBAZEPINE600MGTABLET / ORALAB2008-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078069-001OXCARBAZEPINE150MGTABLET / ORALAB2008-01-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078069-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078069-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078069-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078069-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078069-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078069-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078069-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078069-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078069-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078069-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078069-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078069-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078069-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078069-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078069-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078069-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078069-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE300 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312136Internal RxNorm lookup
312137Internal RxNorm lookup
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
b1d54def-057d-4608-bc8f-1d967ac3ec91Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7263-61OXCARBAZEPINE1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7263-61OXCARBAZEPINE100 in 1 CARTONTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7263-61EA - Each0904-7263040a8e00-552a-4275-86f6-25d8db0cafa312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7263OXCARBAZEPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20240816_b1d54def-057d-4608-bc8f-1d967ac3ec91.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.ffc8d10c-0049-4fe5-beb8-79cc6a197ede2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.85a9bdee-4d10-4097-ae3d-0bf8d844a11b2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticalsb1d54def-057d-4608-bc8f-1d967ac3ec912026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
ndc (product): 0904-7263
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.fcf5044a-8cfd-47d5-9f47-8f6674843c242026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEMajor Pharmaceuticals567c0777-9bc5-45a9-ba25-959dd76d0e052026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBreckenridge Pharmaceutical, Inc.54fb494e-bce4-442d-954a-757f9851e81e2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.244f9a68-5ab4-46b8-a01f-538572fd3c5f2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEGolden State Medical Supply, Inc.b9db5c45-8b51-449b-b4af-1a235c08f1892025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.a1b6a698-f7d9-4adb-9e38-b63e7a85e2b32025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEREMEDYREPACK INC.1176d5f5-3447-4925-aed8-1a1cb4b5989d2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINECoupler LLC3f15c889-4386-850b-e063-6294a90a8dbf2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEPreferred Pharmaceuticals Inc.e156339c-f79e-4a20-b9da-f50bea9482132025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINECardinal Health 107, LLC4ebcb0e5-1c93-4b3f-8749-6835c56afce52025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack38694974-3dc6-42b5-bdf9-b5354e35330b2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd8edaa2b-3bab-4030-a4e3-0c77f76557312024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack78f196d4-110e-45b1-813a-725f52c1a4eb2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepackd3c7a3b8-b9a2-4a5f-98b3-0ed02eca34332024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069
OXCARBAZEPINEOXCARBAZEPINEBryant Ranch Prepack255f64ba-7667-48e6-8599-3b598bf6f4e92024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078069
application number: ANDA078069

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312137OXcarbazepine 300 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312138OXcarbazepine 600 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312136oxcarbazepine 150 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914
312137oxcarbazepine 300 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914
312138oxcarbazepine 600 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914
312136OXcarbazepine 150 MG Oral TabletPSN4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312137OXcarbazepine 300 MG Oral TabletPSN4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312136oxcarbazepine 150 MG Oral TabletSCD4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312137oxcarbazepine 300 MG Oral TabletSCD4ebcb0e5-1c93-4b3f-8749-6835c56afce53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7263-6100904726361100 BLISTER PACK in 1 CARTON (0904-7263-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2022-11-070000-00-00NoNoCurrent