Carbinoxamine Maleate Extended-Release Oral Suspension

Product NDC: 62542-101
11-digit product format: 625420101
Labeler code: 62542
Product ID: 62542-101_4cdb19d3-49f4-c257-e063-6294a90aaabd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbinoxamine Maleate
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Neos Therapeutics, LP
Application: NDA022556
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-06-01
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: 2027-12-31
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
N022556-001	KARBINAL ER	CARBINOXAMINE MALEATE	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2013-03-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022556-001	9522191	2027-06-15		Drug product	2016-12-22
N022556-001	8062667	2029-03-29		Drug product	2013-04-18

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	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbinoxamine Maleate Extended-Release Oral Suspension
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1374770	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
199f46e5-6288-5627-e063-6294a90ae086	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
0a10da58-f2d3-478e-b6c4-93af0553179d	Product name	1	20160714
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
97ec1a04-ce45-92f5-7c19-1642e8f54f83	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62542-101-05	Carbinoxamine Maleate Extended-Release Oral Suspension	480 mL in 1 BOTTLE, PLASTIC	SUSPENSION, EXTENDED RELEASE	480		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62542-101-05	ML - Milliliter	62542-101	18b55b97-b4cf-476a-a2cd-b74516a57cbe	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62542-101	CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [NEOS THERAPEUTICS LP]	1	Current NDC, 1 package rows	20240606_199f46e5-6288-5627-e063-6294a90ae086.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
Karbinal ER	CARBINOXAMINE MALEATE	Aytu Therapeutics, LLC	c40b3f4e-2d71-41a1-a1fc-f64f38724879	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022556 application number: NDA022556
Carbinoxamine Maleate Extended-Release Oral Suspension	CARBINOXAMINE MALEATE	Neos Therapeutics, LP	199f46e5-6288-5627-e063-6294a90ae086	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022556 application number: NDA022556 ndc (product): 62542-101

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
1374770	carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	199f46e5-6288-5627-e063-6294a90ae086	4
1374770	12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension	SCD	199f46e5-6288-5627-e063-6294a90ae086	4
1374770	carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral Suspension	SY	199f46e5-6288-5627-e063-6294a90ae086	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62542-101-05	62542010105	480 mL in 1 BOTTLE, PLASTIC (62542-101-05)	480 ml	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbinoxamine Maleate Extended-Release Oral Suspension	Neos Therapeutics, LP \| Tris Pharma, Inc	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	4