Home NDC 69067-240-20 Carbinoxamine Maleate
Product NDC 69067-240
Requested package NDC 69067-240-20
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69067-240 69067-240-20 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207484-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 6MG TABLET / ORAL AB RS 2016-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207484-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AB RS 2016-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA RS 2016-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207484-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL RS 2016-05-31 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69067-240 CARBINOXAMINE MALEATE TABLET [FOXLAND PHARMACEUTICALS, INC.] 8 Legacy NDC 20240418_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69067-240-20 69067024020 20 TABLET in 1 BOTTLE (69067-240-20) 20 tablet 2017-12-18 0000-00-00 No No Current