CLARINEX-D 12 HOUR

Product NDC: 78206-120
11-digit product format: 782060120
Labeler code: 78206
Product ID: 78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desloratadine and pseudoephedrine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Organon LLC
Application: NDA021313
Marketing category: NDA
Marketing start: 2021-06-01
Substance: DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 2.5; 120 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [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 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
N021313-001	CLARINEX-D 12 HOUR	DESLORATADINE; PSEUDOEPHEDRINE SULFATE	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2006-02-01

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	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021313-001	CLARINEX-D 12 HOUR	2.5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2006-02-01	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	6709676	2021-02-18	U-707	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021313-001	6709676	2021-02-18	U-707	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649	2020-12-19	U-1017	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	6709676	2021-02-18	U-707	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274	2019-07-07		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649	2020-12-19	U-1017	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	6709676	2021-02-18	U-707	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274	2019-07-07		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649	2020-12-19	U-1017	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	6709676	2021-02-18	U-707	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274	2019-07-07		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6100274*PED	2020-01-07		Pediatric extension		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649	2020-12-19	U-1017	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	8187630	2020-12-19	U-1017	Drug product	2012-06-28	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	6709676	2021-02-18	U-707	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021313-001	7618649*PED	2021-06-19		Pediatric extension		`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: CLARINEX-D 12 HOUR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESLORATADINE	2.5 mg/1
PSEUDOEPHEDRINE SULFATE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FVF865388R	Internal UNII lookup
Y9DL7QPE6B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1112248	Internal RxNorm lookup
1112250	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
1af66b7a-4ab8-40d8-abdd-22d3310228a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
01632a31-f1c5-44ea-aa59-efded68c0797	Product name	1	20150716
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78206-120-01	CLARINEX-D 12 HOUR	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-120-01	EA - Each	78206-120	89777c7b-a634-4937-8e90-f02077bda4e2	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-120	CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [ORGANON LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241201_1af66b7a-4ab8-40d8-abdd-22d3310228a8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLARINEX-D 12 HOUR	DESLORATADINE AND PSEUDOEPHEDRINE SULFATE	Organon LLC	1af66b7a-4ab8-40d8-abdd-22d3310228a8	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021313 application number: NDA021313 ndc (product): 78206-120

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FVF865388R	DESLORATADINE	100643-71-8	DESLORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1112250	CLARINEX-D 2.5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	1af66b7a-4ab8-40d8-abdd-22d3310228a8	6
1112248	desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG 12HR Extended Release Oral Tablet	PSN	1af66b7a-4ab8-40d8-abdd-22d3310228a8	6
1112250	12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet [Clarinex-D]	SBD	1af66b7a-4ab8-40d8-abdd-22d3310228a8	6
1112248	12 HR desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet	SCD	1af66b7a-4ab8-40d8-abdd-22d3310228a8	6
1112250	Clarinex-D (desloratadine 2.5 MG / pseudoephedrine sulfate 120 MG) 12 HR Extended Release Oral Tablet	SY	1af66b7a-4ab8-40d8-abdd-22d3310228a8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-120-01	78206012001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)	2021-06-01	0000-00-00	No	No	Current