Desloratadine

Product NDC: 62250-619
11-digit product format: 622500619
Labeler code: 62250
Product ID: 62250-619_efd1035a-228c-69c7-e053-2995a90ac3f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Desloratadine
Dosage form: TABLET
Route: ORAL
Labeler: Belcher Pharmaceuticals,LLC
Application: ANDA078355
Marketing category: ANDA
Marketing start: 2012-05-15
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62250-619		I	Inactivated by FDA	2026-08-17
excluded package	package	62250-619	62250-619-01	I	Inactivated by FDA	2026-08-17
excluded package	package	62250-619	62250-619-02	I	Inactivated by FDA	2026-08-17
excluded package	package	62250-619	62250-619-08	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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62250-619-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62250-619-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62250-619-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62250-619-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62250-619-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62250-619-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A078355-001	DESLORATADINE	DESLORATADINE	5MG	TABLET / ORAL	AB		2012-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078355-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078355-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-04-19	`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	A078355-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078355-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078355-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078355-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078355-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078355-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078355-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078355-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078355-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078355-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078355-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078355-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078355-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078355-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078355-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078355-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078355-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078355-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078355-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078355-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078355-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078355-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078355-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078355-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078355-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078355-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078355-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078355-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078355-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078355-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078355-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078355-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078355-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078355-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078355-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078355-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078355-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078355-001	AB	1	`e64feba35796…`

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
62250-619-01	2025-07-29	C162847	48780-1	3b156c62-2afe-fb37-e063-e6dba90a4e07	Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001
62250-619-02	2025-07-29	C162847	48780-1	3b156c62-2afe-fb37-e063-e6dba90a4e07	Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001
62250-619-08	2025-07-29	C162847	48780-1	3b156c62-2afe-fb37-e063-e6dba90a4e07	Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62250-619-01	Desloratadine	30 in 1 BOTTLE	TABLET	30	12
62250-619-02	Desloratadine	100 in 1 BOTTLE	TABLET	100	12
62250-619-08	Desloratadine	500 in 1 BOTTLE	TABLET	500	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62250-619-02	EA - Each	62250-619	fba87a80-61a3-46ba-bd35-75438edf5fa2	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESLORATADINE	ACTIVE INGREDIENT	FVF865388R	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
DESLORATADINE	ACTIVE MOIETY	FVF865388R	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62250-619	DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]	12	Legacy NDC, 3 package rows	20231006_dbb8e695-f00b-4c67-bd49-09a1ae5bb669.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desloratadine	DESLORATADINE	Bryant Ranch Prepack	cf7f838b-4595-4c81-97b9-e1594347e1bd	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355
Desloratadine	DESLORATADINE	Virtus Pharmaceuticals, LLC	0fe374d0-c14b-4102-b568-eb79165fc7ef	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355
Desloratadine	DESLORATADINE	A-S Medication Solutions	36307c2b-6b6a-46a9-9fe4-1798fc72e7b8	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078355 application number: ANDA078355

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
349420	desloratadine 5 MG Oral Tablet	PSN	dbb8e695-f00b-4c67-bd49-09a1ae5bb669	12
349420	desloratadine 5 MG Oral Tablet	SCD	dbb8e695-f00b-4c67-bd49-09a1ae5bb669	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62250-619-01	62250061901	30 TABLET in 1 BOTTLE (62250-619-01)	30 tablet	2012-12-28	0000-00-00	No	No	Current
62250-619-02	62250061902	100 TABLET in 1 BOTTLE (62250-619-02)	100 tablet	2012-12-28	0000-00-00	No	No	Current
62250-619-08	62250061908	500 TABLET in 1 BOTTLE (62250-619-08)	500 tablet	2018-12-28	0000-00-00	No	No	Current