Desloratadine

Product NDC: 0378-4017
11-digit product format: 003784017
Labeler code: 0378
Product ID: 0378-4017_b20c1ca2-b5d2-4499-bf15-79bfef0ecdb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: desloratadine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA078351
Marketing category: ANDA
Marketing start: 2012-07-02
Marketing end: 2019-06-30
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-4017		D	Discontinued by firm	2026-08-17
excluded package	package	0378-4017	0378-4017-01	D	Discontinued by firm	2026-08-17
excluded package	package	0378-4017	0378-4017-05	D	Discontinued by firm	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 · 36 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	0378-4017-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-4017-01	`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	0378-4017-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-4017-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-4017-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-4017-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-4017-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-4017-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-4017-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-4017-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-4017-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-4017-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-4017-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-4017-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-4017-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-4017-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-4017-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-4017-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4017-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4017-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4017-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4017-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4017-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4017-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078351-001	DESLORATADINE	DESLORATADINE	5MG	TABLET / ORAL	AB		2012-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078351-001	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	A078351-001	DESLORATADINE	5MG	TABLET / ORAL	AB	2012-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078351-001	DESLORATADINE	5MG	TABLET / ORAL		2012-02-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078351-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078351-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4017-01	EA - Each	0378-4017	31893ca1-9c7b-41ed-bfaf-029a665f87f5	1	2013-02-13
0378-4017-05	EA - Each	0378-4017	69a7e10a-2925-4c11-a45c-0dc6aad2fc18	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESLORATADINE	ACTIVE INGREDIENT	FVF865388R	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
DESLORATADINE	ACTIVE MOIETY	FVF865388R	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DESLORATADINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5

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
Desloratadine	DESLORATADINE	Natco Pharma USA LLC	e4db30a5-48e5-4fe3-8793-30b6866f87c1	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078351 application number: ANDA078351