CARBZAH

Product NDC: 71085-080
11-digit product format: 710850080
Labeler code: 71085
Product ID: 71085-080_37b3e7c3-81ea-3a36-e063-6294a90a3d9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbinoxamine Maleate
Dosage form: SOLUTION
Route: ORAL
Labeler: IPG Pharmaceuticals, inc.
Application: ANDA040458
Marketing category: ANDA
Marketing start: 2025-06-01
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	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: CARBZAH
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
2730039	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a845fc15-c675-4e33-840c-6a74e79d0ced	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
78df9296-6f14-4da6-be68-48f965578efc	Product name	2	20250814
0a10da58-f2d3-478e-b6c4-93af0553179d	Product name	1	20160714
97ec1a04-ce45-92f5-7c19-1642e8f54f83	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71085-080-07	CARBZAH	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71085-080-07	ML - Milliliter	71085-080	aa4c356f-605d-4aa9-9fc8-de540bc934bb	1	2025-08-11

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 ndc (product): 71085-080
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010696	carbinoxamine maleate 4 MG in 5 mL Oral Solution	PSN	a845fc15-c675-4e33-840c-6a74e79d0ced	3
2730039	CARBZAH 4 MG in 5 mL Oral Solution	PSN	a845fc15-c675-4e33-840c-6a74e79d0ced	3
2730039	carbinoxamine maleate 0.8 MG/ML Oral Solution [Carbzah]	SBD	a845fc15-c675-4e33-840c-6a74e79d0ced	3
1010696	carbinoxamine maleate 0.8 MG/ML Oral Solution	SCD	a845fc15-c675-4e33-840c-6a74e79d0ced	3
1010696	carbinoxamine maleate 0.8 MG/ML Oral Syrup	SY	a845fc15-c675-4e33-840c-6a74e79d0ced	3
1010696	carbinoxamine maleate 4 MG per 5 ML Oral Solution	SY	a845fc15-c675-4e33-840c-6a74e79d0ced	3
2730039	Carbzah 4 MG per 5 ML Oral Solution	SY	a845fc15-c675-4e33-840c-6a74e79d0ced	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71085-080-07	71085008007	473 mL in 1 BOTTLE, PLASTIC (71085-080-07)	473 ml	2025-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBZAH Carbinoxamine Maleate Oral Solution, 4 mg/5 mL	IPG Pharmaceuticals, inc.	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL	3