CARBAMAZEPINE

Product NDC
0904-3854
11-digit product format
009043854
Labeler code
0904
Product ID
0904-3854_4da43d38-dcd6-4447-8693-5e41e78aacbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075712
Marketing category
ANDA
Marketing start
2010-03-22
Substance
CARBAMAZEPINE
Active strength
100 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 packagepackage0904-38540904-3854-80DDiscontinued by firm2026-08-17

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 · 11 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075712-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075712-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-053f01610625f2…
2019-09-15 20:21 UTC2019-09A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075712-001CARBAMAZEPINE100MGTABLET, CHEWABLE / ORALAB2001-07-05e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075712-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075712-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075712-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075712-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075712-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075712-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075712-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075712-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075712-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075712-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075712-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075712-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075712-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075712-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075712-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075712-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075712-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075712-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075712-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075712-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075712-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075712-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075712-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075712-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075712-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075712-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075712-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075712-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075712-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075712-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075712-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075712-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075712-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075712-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075712-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075712-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075712-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075712-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075712-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075712-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308973Internal RxNorm lookup
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
2a8c7366-ce89-47ce-8123-96f26812fca0Available 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
0904-3854-61CARBAMAZEPINE1 in 1 BLISTER PACKTABLET, CHEWABLE127
0904-3854-61CARBAMAZEPINE100 in 1 CARTONTABLET, CHEWABLE10027
0904-3854-80CARBAMAZEPINE1000 in 1 BOTTLETABLET, CHEWABLE100027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-3854-61EA - Each0904-385415df8747-2cb4-4e4e-afb6-4556fa27b97c12012-07-24
0904-3854-80EA - Each0904-3854c2e56bec-89b1-4e0a-ad4a-e10266c2ddd312018-03-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-3854CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET [MAJOR PHARMACEUTICALS]24Current NDC, Legacy NDC, 3 package rows20250507_2a8c7366-ce89-47ce-8123-96f26812fca0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
CARBAMAZEPINECARBAMAZEPINEMajor Pharmaceuticals2a8c7366-ce89-47ce-8123-96f26812fca02026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
ndc (product): 0904-3854
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
CARBAMAZEPINECARBAMAZEPINEBryant Ranch Prepackc72a0668-7cd7-46a8-86d1-d3c17c4b900f2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712
CarbamazepineCARBAMAZEPINEAmerican Health Packagingf8444c23-a74f-4d44-867e-26554dbb882f2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075712
application number: ANDA075712

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308973carBAMazepine 100 MG Chewable TabletPSN2a8c7366-ce89-47ce-8123-96f26812fca027
308979carBAMazepine 200 MG Oral TabletPSN2a8c7366-ce89-47ce-8123-96f26812fca027
308973carbamazepine 100 MG Chewable TabletSCD2a8c7366-ce89-47ce-8123-96f26812fca027
308979carbamazepine 200 MG Oral TabletSCD2a8c7366-ce89-47ce-8123-96f26812fca027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-3854-6100904385461100 BLISTER PACK in 1 CARTON (0904-3854-61) / 1 TABLET, CHEWABLE in 1 BLISTER PACK100 blister pack2010-03-220000-00-00NoNoCurrent
0904-3854-80009043854801000 TABLET, CHEWABLE in 1 BOTTLE (0904-3854-80) 2010-03-220000-00-00NoNoCurrent