Home NDC 64950-243 Carbinoxamine Maleate
Product NDC 64950-243
11-digit product format 649500243
Labeler code 64950
Product ID 64950-243_12a85f25-d18a-4408-8c66-4e0182287026
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbinoxamine Maleate
Dosage form SOLUTION
Route ORAL
Labeler Genus Lifesciences Inc.
Application ANDA040458
Marketing category ANDA
Marketing start 2023-06-09
Substance CARBINOXAMINE MALEATE
Active strength 4 mg/5mL
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 A040458-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25
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 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040458-001 CARBINOXAMINE MALEATE 4MG/5ML SOLUTION / ORAL RS 2003-04-25 e64feba35796…
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/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010696 Internal RxNorm lookup 1012904 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 64950-243-04 Carbinoxamine Maleate 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 6 64950-243-16 Carbinoxamine Maleate 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-243 CARBINOXAMINE MALEATE SOLUTION CARBINOXAMINE MALEATE TABLET [GENUS LIFESCIENCES INC.] 6 Current NDC, 2 package rows 20240315_9d11b197-cfdc-4b9b-9935-2920ccb6e522.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64950-243-04 64950024304 118 mL in 1 BOTTLE, PLASTIC (64950-243-04) 118 ml 2023-06-09 No No Current 64950-243-16 64950024316 473 mL in 1 BOTTLE, PLASTIC (64950-243-16) 473 ml 2023-06-09 No No Current