Loratadine

Product NDC: 0363-0771
Requested package NDC: 0363-0771-01
11-digit product format: 003630771
Labeler code: 0363
Product ID: 0363-0771_43cfee1f-c7e3-6db4-e063-6294a90a5b4d
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: WALGREEN COMPANY
Application: ANDA201865
Marketing category: ANDA
Marketing start: 2023-04-19
Substance: LORATADINE
Active strength: 5 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A201865-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2015-07-31

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201865-001	LORATADINE	1MG/ML	SYRUP / ORAL	2015-07-31	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692783	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
3881afaf-8d0d-4154-85a8-79a3c7806b49	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0363-0771-01	Loratadine
0363-0771-01	Loratadine
0363-0771-08	Loratadine
0363-0771-08	Loratadine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0771-01	Loratadine	240 mL in 1 BOTTLE	SOLUTION	240	5
0363-0771-01	Loratadine	1 in 1 CARTON	SOLUTION	1	5
0363-0771-08	Loratadine	1 in 1 CARTON	SOLUTION	1	5
0363-0771-08	Loratadine	120 mL in 1 BOTTLE	SOLUTION	120	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Loratadine Sugar Free	LORATADINE	Sun Pharmaceutical Industries, Inc.	96a76906-58ad-40cd-be27-4ea254e298c5	2026-07-14	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865
Loratadine	LORATADINE	WALGREEN COMPANY	3881afaf-8d0d-4154-85a8-79a3c7806b49	2025-11-17	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865 ndc (package): 0363-0771-01 ndc (product): 0363-0771 ndc11 (package): 00363077101
Childrens Allergy	LORATADINE	Wal-Mart Stores Inc	9fb3a3a8-8812-4238-b596-291b79085db9	2021-04-15	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865
Childrens Walitin	LORATADINE	Walgreen Company	f7962107-f79a-4a04-af8d-f7b989e51f2c	2019-01-15	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865
Childrens Allergy	LORATADINE	CVS Pharmacy	dc5f58ef-baf0-4de4-9f6d-aedee419b59b	2017-10-02	Warnings	Exact identifier application applno (ANDA): 201865 application number: ANDA201865

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	3881afaf-8d0d-4154-85a8-79a3c7806b49	5
692783	loratadine 1 MG/ML Oral Solution	SCD	3881afaf-8d0d-4154-85a8-79a3c7806b49	5
692783	loratadine 5 MG per 5 ML Oral Solution	SY	3881afaf-8d0d-4154-85a8-79a3c7806b49	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0363-0771-01	00363077101	1 BOTTLE in 1 CARTON (0363-0771-01) / 240 mL in 1 BOTTLE	1 bottle	2023-04-19	No	No	Current