Home NDC 51991-333 Carbinoxamine Maleate
Product NDC 51991-333
11-digit product format 519910333
Labeler code 51991
Product ID 51991-333_e95a03c6-f423-7177-e053-2a95a90a0add
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbinoxamine maleate
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA040442
Marketing category ANDA
Marketing start 2012-12-10
Marketing end 2025-06-09
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51991-333-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51991-333-01 f5e01cc5f278…a2eaf40c39c3…
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 [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 CARBINOXAMINE ACTIVE MOIETY 982A7M02H5 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-333 CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.] 8 Legacy NDC 20220924_1edca669-8879-408a-b09c-259e363dd95c.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51991-333-01 51991033301 100 TABLET in 1 BOTTLE, PLASTIC (51991-333-01) 100 tablet 2012-12-10 0000-00-00 No No Current