Home NDC 46672-191 carbinoxamine maleate
Product NDC 46672-191
11-digit product format 466720191
Labeler code 46672
Product ID 46672-191_a62ab885-5e2f-5b5b-e053-2995a90a8d44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbinoxamine maleate
Dosage form TABLET
Route ORAL
Labeler Mikart, LLC
Application ANDA040442
Marketing category ANDA
Marketing start 2003-03-19
Marketing end 0000-00-00
Substance CARBINOXAMINE MALEATE
Active strength 4 mg/1
Pharmacologic classes Histamine-1 Receptor Antagonist [EPC],Histamine H1 Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 A040442-001 CARBINOXAMINE MALEATE CARBINOXAMINE MALEATE 4MG TABLET / ORAL 2003-03-19
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 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL 2003-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040442-001 CARBINOXAMINE MALEATE 4MG TABLET / ORAL AA RS 2003-03-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBINOXAMINE MALEATE ACTIVE INGREDIENT 02O55696WH CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 CARBINOXAMINE ACTIVE MOIETY 982A7M02H5 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [MIKART, INC.] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46672-191-10 46672019110 100 TABLET in 1 BOTTLE, PLASTIC (46672-191-10) 100 tablet 2003-03-19 0000-00-00 No No Current 46672-191-50 46672019150 500 TABLET in 1 BOTTLE, PLASTIC (46672-191-50) 500 tablet 2003-03-19 0000-00-00 No No Current