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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090756-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090756-001 AA
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.
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 2026-08-01 22:54:32 2026-06 A090756-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA 2011-05-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A090756-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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