OXCARBAZEPINE

Product NDC
70518-0894
11-digit product format
705180894
Labeler code
70518
Product ID
70518-0894_e29650e8-7845-bb71-e053-2a95a90ad0d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2017-12-12
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-0894DDiscontinued by firm2026-08-10
excluded packagepackage70518-089470518-0894-0DDiscontinued by firm2026-08-10
excluded packagepackage70518-089470518-0894-1DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0894OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]15Legacy NDC20250503_dbef7bb3-94aa-4cb3-a0ae-01b20f806a7e.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0894-07051808940030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0894-0) 2017-12-120000-00-00NoNoCurrent
70518-0894-170518089401100 POUCH in 1 BOX (70518-0894-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0894-2) 100 pouch2020-04-090000-00-00NoNoCurrent