Home NDC 80705-120 Carbinoxamine Maleate
Product NDC 80705-120
11-digit product format 807050120
Labeler code 80705
Product ID 80705-120_28237aea-8a3c-40ca-b2a1-0b7248ce5b99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbinoxamine Maleate
Dosage form TABLET
Route ORAL
Labeler TRIPOINT THERAPEUTICS, LLC
Application ANDA215476
Marketing category ANDA
Marketing start 2025-07-22
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 2026-12-31
Current FDA listing Yes 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 A215476-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 6MG TABLET / ORAL AB 2024-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215476-001 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.
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 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AB 2024-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AA 2024-12-19 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215476-001 CARBINOXAMINE MALEATE 6MG TABLET / ORAL AB 2024-12-19 a50c72e98297…
Observed Orange Book normalized TE history# 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 6 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 1795581 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80705-120-30 Carbinoxamine Maleate 30 in 1 BOTTLE TABLET 30 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80705-120-30 80705012030 30 TABLET in 1 BOTTLE (80705-120-30) 30 tablet 2025-07-22 No No Current