CARBAMAZEPINE

Product NDC
17856-0029
11-digit product format
178560029
Labeler code
17856
Product ID
17856-0029_8fe5545e-d942-4062-bb81-7b554b58ef6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA075714
Marketing category
ANDA
Marketing start
2002-06-05
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/5mL
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0029IInactivated by FDA2026-08-11
excluded packagepackage17856-002917856-0029-1IInactivated 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 packagepackage17856-0029-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0029-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0029-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0029-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0029-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0029-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0029-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0029-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0029-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0029-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0029-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0029-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0029-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0029-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0029-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0029-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0029-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0029-1bd6a592717d7…303034d00443…

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

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
A075714-001CARBAMAZEPINECARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075714-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075714-001CARBAMAZEPINE100MG/5MLSUSPENSION / ORALAB2002-06-05cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075714-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075714-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075714-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075714-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075714-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075714-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075714-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075714-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075714-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075714-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075714-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075714-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075714-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075714-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075714-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075714-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075714-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075714-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075714-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075714-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075714-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075714-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075714-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075714-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075714-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075714-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075714-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075714-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075714-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075714-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075714-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075714-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075714-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075714-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075714-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075714-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075714-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075714-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075714-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075714-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0029-1CARBAMAZEPINE72 in 1 BOX, UNIT-DOSESUSPENSION722
17856-0029-2CARBAMAZEPINE10 mL in 1 CUP, UNIT-DOSESUSPENSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0029CARBAMAZEPINE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 2 package rows20220927_364aa931-f090-406b-8e79-c44e7592520e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEChartwell Governmental & Specialty RX, LLC.35298eaf-3478-4dfb-a629-298dd52713f02025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075714
application number: ANDA075714
CarbamazepineCARBAMAZEPINEChartwell RX, LLC8d5ace90-983b-48c4-baf1-b44f6af146de2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075714
application number: ANDA075714

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308976carBAMazepine 100 MG in 5 mL Oral SuspensionPSN364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 20 MG/ML Oral SuspensionSCD364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 100 MG per 5 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2
308976carbamazepine 200 MG per 10 ML Oral SuspensionSY364aa931-f090-406b-8e79-c44e7592520e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0029-11785600290172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0029-1) > 10 mL in 1 CUP, UNIT-DOSE2020-04-100000-00-00NoNoCurrent
17856-0029-21785600290210 mL in 1 CUP, UNIT-DOSE10 mlHistorical