Carbinoxamine Maleate

Product NDC: 51991-334
11-digit product format: 519910334
Labeler code: 51991
Product ID: 51991-334_e95a03c6-f423-7177-e053-2a95a90a0add
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbinoxamine maleate
Dosage form: SYRUP
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA040458
Marketing category: ANDA
Marketing start: 2012-12-10
Marketing end: 2025-03-15
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51991-334		D	Discontinued by firm		2026-08-17
excluded package	package	51991-334	51991-334-04	D	Discontinued by firm		2026-08-17

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 · 8 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	51991-334-04	`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	51991-334-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51991-334-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51991-334-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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	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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-334-04	ML - Milliliter	51991-334	018249a0-b3b6-4821-a532-c4fbca3d4f1e	1	2013-04-01
51991-334-16	ML - Milliliter	51991-334	0d52a3ae-f954-4a7c-8828-a11853d4b750	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
51991-334	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBZAH	CARBINOXAMINE MALEATE	IPG Pharmaceuticals, inc.	a845fc15-c675-4e33-840c-6a74e79d0ced	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040458 application number: ANDA040458
Carbinoxamine Maleate	CARBINOXAMINE MALEATE	Genus Lifesciences Inc.	9d11b197-cfdc-4b9b-9935-2920ccb6e522	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040458 application number: ANDA040458

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02O55696WH	CARBINOXAMINE MALEATE	3505-38-2	CARBINOXAMINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-334-04	51991033404	118 mL in 1 BOTTLE, PLASTIC (51991-334-04)	118 ml	2012-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbinoxamine Maleate - Breckenridge Pharmaceutical, Inc.	Breckenridge Pharmaceutical, Inc.	2022-09-23	HUMAN PRESCRIPTION DRUG LABEL	8