carbinoxamine maleate

Product NDC: 46672-644
11-digit product format: 466720644
Labeler code: 46672
Product ID: 46672-644_a62ab885-5e2f-5b5b-e053-2995a90a8d44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbinoxamine maleate
Dosage form: SYRUP
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040458
Marketing category: ANDA
Marketing start: 2003-04-25
Marketing end: 0000-00-00
Substance: CARBINOXAMINE MALEATE
Active strength: 4 mg/5mL
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
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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 · 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
46672-644-04	46672064404	118 mL in 1 BOTTLE, PLASTIC (46672-644-04)	118 ml	2003-04-25	0000-00-00	No	No	Current
46672-644-16	46672064416	473 mL in 1 BOTTLE, PLASTIC (46672-644-16)	473 ml	2003-04-25	0000-00-00	No	No	Current

carbinoxamine maleate

Orange Book products#

Observed Orange Book product history#

DailyMed Socrata Ingredients#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#