Carbamazepine

Product NDC
70518-2841
11-digit product format
705182841
Labeler code
70518
Product ID
70518-2841_50acf39d-5e31-9cd7-e063-6294a90a6de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207798
Marketing category
ANDA
Marketing start
2020-08-19
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
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 packagepackage70518-284170518-2841-0DDiscontinued by firm2026-08-11

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-2841-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2841-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-2841-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2841-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-2841-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-2841-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-2841-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-2841-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-2841-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-2841-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-2841-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-2841-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-2841-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-2841-3557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207798-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET / ORALBX2020-04-15
A207798-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORALBX2020-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207798-001BX
A207798-002BX

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-001CARBAMAZEPINE100MGTABLET / ORALBX2020-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-002CARBAMAZEPINE200MGTABLET / ORALBX2020-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-001CARBAMAZEPINE100MGTABLET / ORALAB2020-04-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-002CARBAMAZEPINE200MGTABLET / ORALAB2020-04-1587673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207798-001BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207798-002BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-001BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207798-002BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207798-001BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207798-002BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-001BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207798-002BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-001BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207798-002BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-001BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207798-002BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207798-002BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207798-002BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207798-002BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207798-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207798-002BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207798-002BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207798-002BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207798-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207798-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207798-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207798-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207798-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207798-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207798-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207798-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207798-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207798-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207798-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207798-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207798-002AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33CM23913MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308979Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2841-0Carbamazepine30 in 1 BLISTER PACKTABLET3017
70518-2841-1Carbamazepine100 in 1 BOXTABLET10017
70518-2841-2Carbamazepine1 in 1 POUCHTABLET117
70518-2841-3Carbamazepine30 in 1 BLISTER PACKTABLET3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2841-1EA - Each70518-28415bf9d7eb-8b29-4dfa-8fbc-5b072758781712026-02-05
70518-2841-2EA - Each70518-2841ade11306-436f-4315-84d8-f6b3fd3ed96a12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2841CARBAMAZEPINE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 4 package rows20250501_9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2.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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
ndc (product): 70518-2841
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEBryant Ranch Prepack62d38b93-7dd0-48e7-bd59-a434d52520f62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEPreferred Pharmaceuticals Inc.867a5f4d-8ae6-4339-bbb4-0bf62fb082e52026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINENIVAGEN PHARMACEUTICALS, INC.e68998cb-5f91-4d7e-85a6-555efb8b03842025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CarbamazepineCARBAMAZEPINEA-S Medication Solutions047bc284-060a-4db9-bf37-75d10f95a0a62025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798
CARBAMAZEPINECARBAMAZEPINEdirect rxb56dd9c8-1bca-21e3-e053-2995a90a3e6e2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207798
application number: ANDA207798

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217
308979carbamazepine 200 MG Oral TabletSCD9f3d91cd-a959-4e07-a51b-8a4e9ba9ece217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2841-07051828410030 TABLET in 1 BLISTER PACK (70518-2841-0) 30 tablet2020-08-190000-00-00NoNoCurrent
70518-2841-170518284101100 POUCH in 1 BOX (70518-2841-1) / 1 TABLET in 1 POUCH (70518-2841-2) 100 pouch2022-02-080000-00-00NoNoCurrent
70518-2841-2705182841021 in 1 POUCHHistorical
70518-2841-37051828410330 TABLET in 1 BLISTER PACK (70518-2841-3) 30 tablet2021-08-090000-00-00NoNoCurrent