Home NDC 44523-825 Carbinoxamine Maleate
Product NDC 44523-825
11-digit product format 445230825
Labeler code 44523
Product ID 44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbinoxamine Maleate
Dosage form TABLET
Route ORAL
Labeler Biocomp Pharma, Inc.
Application ANDA090756
Marketing category ANDA
Marketing start 2011-05-27
Substance CARBINOXAMINE MALEATE
Active strength 4 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 44523-825 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 44523-825 44523-825-01 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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 A090756-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 4MG TABLET / ORAL RS 2011-05-27
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 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL RS 2011-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Carbinoxamine Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBINOXAMINE MALEATE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 02O55696WH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012904 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44523-825-01 Carbinoxamine Maleate 100 in 1 BOTTLE TABLET 100 8 44523-825-01 Carbinoxamine Maleate 1 in 1 CARTON TABLET 1 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-825 CARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240308_14266e97-674b-b6a9-37a2-a955f0a01c4f.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44523-825-01 44523082501 1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE 1 bottle 2021-06-28 0000-00-00 No No Current