Karbinal

Product NDC: 23594-101
Requested package NDC: 23594-101-05
11-digit product format: 235940101
Labeler code: 23594
Product ID: 23594-101_4cd73883-efb6-9773-e063-6394a90a8285
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbinoxamine Maleate
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Aytu Therapeutics, LLC
Application: NDA022556
Marketing category: NDA
Marketing start: 2014-01-03
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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Karbinal
Brand name suffix: ER
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1374770	Internal RxNorm lookup
1374776	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
c40b3f4e-2d71-41a1-a1fc-f64f38724879	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
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
0a10da58-f2d3-478e-b6c4-93af0553179d	Product name	1	20160714
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	SPL version
23594-101-01	KarbinalER	30 mL in 1 BOTTLE, PLASTIC	SUSPENSION, EXTENDED RELEASE	30	15
23594-101-01	KarbinalER	2 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	2	15
23594-101-05	KarbinalER	480 mL in 1 BOTTLE, PLASTIC	SUSPENSION, EXTENDED RELEASE	480	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23594-101-05	ML - Milliliter	23594-101	94c93b3b-10fa-46d8-8416-ba7d0f3029fe	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23594-101	KARBINAL ER (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC]	14	Current NDC, Legacy NDC, 3 package rows	20250110_c40b3f4e-2d71-41a1-a1fc-f64f38724879.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 ndc (package): 23594-101-05 ndc (product): 23594-101 ndc11 (package): 23594010105
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

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	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374776	Karbinal ER 4 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374776	12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal]	SBD	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374770	12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension	SCD	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374776	12 HR Karbinal 0.8 MG/ML Extended Release Suspension	SY	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374770	carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral Suspension	SY	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15
1374776	Karbinal 4 MG per 5 ML 12 HR Extended Release Suspension	SY	c40b3f4e-2d71-41a1-a1fc-f64f38724879	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23594-101-05	23594010105	480 mL in 1 BOTTLE, PLASTIC (23594-101-05)	480 ml	2014-01-03	0000-00-00	No	No	Current