CARBAMAZEPINE

Product NDC
67046-096
11-digit product format
670460096
Labeler code
67046
Product ID
67046-096_5940711d-71a8-cb7d-e053-2a91aa0aef18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBAMAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077272
Marketing category
ANDA
Marketing start
2009-10-23
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-096IInactivated by FDA2026-08-11
excluded packagepackage67046-09667046-096-30IInactivated by FDA2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-096-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-096-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-096-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-096-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-096-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-096-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-096-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-096-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-096-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-096-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-096-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-096-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-096-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-096-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-096-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-096-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-096-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-096-30bd6a592717d7…303034d00443…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077272-001CARBAMAZEPINECARBAMAZEPINE100MGTABLET / ORAL2005-12-07
A077272-002CARBAMAZEPINECARBAMAZEPINE200MGTABLET / ORALAB2005-12-07
A077272-003CARBAMAZEPINECARBAMAZEPINE300MGTABLET / ORAL2005-12-07
A077272-004CARBAMAZEPINECARBAMAZEPINE400MGTABLET / ORAL2005-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077272-002AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077272-001CARBAMAZEPINE100MGTABLET / ORAL2005-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-001CARBAMAZEPINE100MGTABLET / ORALAB2005-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-001CARBAMAZEPINE100MGTABLET / ORALAB2005-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-001CARBAMAZEPINE100MGTABLET / ORALAB2005-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077272-001CARBAMAZEPINE100MGTABLET / ORALAB2005-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077272-002CARBAMAZEPINE200MGTABLET / ORALAB2005-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077272-003CARBAMAZEPINE300MGTABLET / ORAL2005-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077272-004CARBAMAZEPINE400MGTABLET / ORAL2005-12-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077272-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077272-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077272-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077272-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077272-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077272-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077272-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077272-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077272-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077272-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077272-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077272-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077272-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077272-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077272-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077272-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077272-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077272-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077272-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077272-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077272-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077272-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077272-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077272-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077272-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077272-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077272-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077272-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077272-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077272-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077272-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077272-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077272-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077272-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077272-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077272-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077272-001AB1c0c555d07b60…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-096-302022-01-28C16284748780-1d6a99b39-4e7b-a426-e053-dadaa90af4c2Carbamazepine Tablets, USP 200 mg 096

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-096-30CARBAMAZEPINE30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-096CARBAMAZEPINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170918_5940711d-71a7-cb7d-e053-2a91aa0aef18.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 · 3 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): 077272
application number: ANDA077272
CARBAMAZEPINECARBAMAZEPINEMajor Pharmaceuticals2a8c7366-ce89-47ce-8123-96f26812fca02026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077272
application number: ANDA077272
CarbamazepineCARBAMAZEPINECardinal Health 107, LLC232ef732-ee6d-4ac7-8e78-c619b611fbbe2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077272
application number: ANDA077272

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308979carBAMazepine 200 MG Oral TabletPSN5940711d-71a7-cb7d-e053-2a91aa0aef181
308979carbamazepine 200 MG Oral TabletSCD5940711d-71a7-cb7d-e053-2a91aa0aef181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-096-306704600963030 TABLET in 1 BLISTER PACK (67046-096-30) 30 tablet2017-09-180000-00-00NoNoCurrent