OXCARBAZEPINE

Product NDC
70518-2253
11-digit product format
705182253
Labeler code
70518
Product ID
70518-2253_4dd9ce1d-3f6f-4190-e063-6294a90aabc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2019-08-05
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-225370518-2253-1DDiscontinued by firm2026-08-07

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 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…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE150 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
312136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b571ee0f-3c2a-4c55-9c2b-e00014e2ec7aAvailable 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
70518-2253-0OXCARBAZEPINE30 in 1 BLISTER PACKTABLET, FILM COATED3015
70518-2253-1OXCARBAZEPINE100 in 1 BOXTABLET, FILM COATED10015
70518-2253-2OXCARBAZEPINE1 in 1 POUCHTABLET, FILM COATED115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2253OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250524_b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a.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
ndc (product): 70518-2253
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb571ee0f-3c2a-4c55-9c2b-e00014e2ec7a15
312136oxcarbazepine 150 MG Oral TabletSCDb571ee0f-3c2a-4c55-9c2b-e00014e2ec7a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2253-07051822530030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2253-0) 2019-08-050000-00-00NoNoCurrent
70518-2253-170518225301100 POUCH in 1 BOX (70518-2253-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2253-2) 100 pouch2021-08-030000-00-00NoNoCurrent
70518-2253-2705182253021 in 1 POUCHHistorical