Clarinex

Product NDC: 50090-0765
Requested package NDC: 50090-0765-0
11-digit product format: 500900765
Labeler code: 50090
Product ID: 50090-0765_39a6d7f8-a5b1-4dbb-a1d2-ba8e9536ff48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desloratadine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021165
Marketing category: NDA
Marketing start: 2001-12-21
Marketing end: 0000-00-00
Substance: DESLORATADINE
Active strength: 5 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0765	50090-0765-0	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
N021165-001	CLARINEX	DESLORATADINE	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021165-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021165-001	CLARINEX	5MG	TABLET / ORAL	AB	RLD, RS	2001-12-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021165-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021165-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021165-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021165-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021165-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021165-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021165-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021165-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021165-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021165-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021165-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021165-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021165-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021165-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021165-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021165-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021165-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021165-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021165-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021165-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021165-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021165-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021165-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021165-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021165-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021165-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021165-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021165-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021165-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021165-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021165-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021165-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021165-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021165-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021165-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021165-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021165-001	6100274	2019-07-07			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	7405223	2019-07-07	U-886		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021165-001	6100274	2019-07-07			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	7405223	2019-07-07	U-886		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021165-001	6100274	2019-07-07			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	7405223	2019-07-07	U-886		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021165-001	6100274	2019-07-07			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	7405223	2019-07-07	U-886		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	6100274*PED	2020-01-07		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021165-001	7405223*PED	2020-01-07		Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
01632a31-f1c5-44ea-aa59-efded68c0797	Product name	1	20150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0765-0	2023-01-30	C162847	48780-1	f386c649-b6dd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CLARINEX safely and effectively. See full prescribing information for CLARINEX. CLARINEX ® (desloratadine) Tablets, RediTabs ® , and Oral Solution for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-0765-0	Clarinex	30 in 1 BOTTLE	TABLET, FILM COATED	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0765-0	EA - Each	50090-0765	e649b574-7ec1-4fa0-9364-1eb10e298120	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0765	CLARINEX (DESLORATADINE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 1 package rows	20210219_a7b5d043-da63-499c-b8bd-adf9295a6975.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	DESLORATADINE	Organon LLC	c671342e-69a2-4ca5-abc2-8166ed4240d4	2025-05-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021165 application number: NDA021165

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FVF865388R	DESLORATADINE	100643-71-8	DESLORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
352086	CLARINEX 5 MG Oral Tablet	PSN	a7b5d043-da63-499c-b8bd-adf9295a6975	7
349420	desloratadine 5 MG Oral Tablet	PSN	a7b5d043-da63-499c-b8bd-adf9295a6975	7
352086	desloratadine 5 MG Oral Tablet [Clarinex]	SBD	a7b5d043-da63-499c-b8bd-adf9295a6975	7
349420	desloratadine 5 MG Oral Tablet	SCD	a7b5d043-da63-499c-b8bd-adf9295a6975	7
352086	Clarinex 5 MG Oral Tablet	SY	a7b5d043-da63-499c-b8bd-adf9295a6975	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0765-0	50090076500	30 TABLET, FILM COATED in 1 BOTTLE (50090-0765-0)	2014-11-28	0000-00-00	No	No	Current