Carbinoxamine Maleate

Product NDC
69067-240
11-digit product format
690670240
Labeler code
69067
Product ID
69067-240_ed0c7764-36b2-2670-e053-2a95a90a8e34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBINOXAMINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Foxland Pharmaceuticals, Inc.
Application
ANDA207484
Marketing category
ANDA
Marketing start
2017-12-18
Marketing end
0000-00-00
Substance
CARBINOXAMINE MALEATE
Active strength
6 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 productproduct69067-240DDiscontinued by firm2026-08-17
excluded packagepackage69067-24069067-240-20DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct69067-240DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69067-24069067-240-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A207484-001CARBINOXAMINE MALEATECARBINOXAMINE MALEATE6MGTABLET / ORALABRS2016-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207484-001AB

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 06:07:402026-07A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALABRS2016-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALAARS2016-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207484-001CARBINOXAMINE MALEATE6MGTABLET / ORALRS2016-05-31e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207484-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207484-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207484-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207484-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207484-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207484-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207484-001AA103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207484-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78df9296-6f14-4da6-be68-48f965578efcProduct name220250814
0a10da58-f2d3-478e-b6c4-93af0553179dProduct name120160714
97ec1a04-ce45-92f5-7c19-1642e8f54f83Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69067-240-20EA - Each69067-2404de313a8-b216-4ca6-95b6-2f0882f4809812018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69067-240CARBINOXAMINE MALEATE TABLET [FOXLAND PHARMACEUTICALS, INC.]8Legacy NDC20240418_b25c8f34-0a46-4685-93a5-ba36a23817ac.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
Carbinoxamine MaleateCARBINOXAMINE MALEATEBluCrest Pharmaceuticals, LLC163db29b-f035-6696-e063-6294a90a7e062026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207484
application number: ANDA207484
RyVentCARBINOXAMINE MALEATECarwin Pharmaceutical Associates, LLC13ed76c7-49bd-4527-83dc-b4c7d0da9fff2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207484
application number: ANDA207484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69067-240-206906702402020 TABLET in 1 BOTTLE (69067-240-20) 20 tablet2017-12-180000-00-00NoNoCurrent