Loratadine

Product NDC: 50090-3620
Requested package NDC: 50090-3620-5
11-digit product format: 500903620
Labeler code: 50090
Product ID: 50090-3620_f64c925a-d437-46fa-9dc8-158a824f8d38
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075209
Marketing category: ANDA
Marketing start: 2016-02-01
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50090-3620	50090-3620-5	I	Inactivated by FDA		2026-08-10

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 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
A075209-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-01-21

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50090-3620-0	Drug Facts
50090-3620-1	Drug Facts
50090-3620-3	Drug Facts
50090-3620-4	Drug Facts
50090-3620-5	Drug Facts
50090-3620-6	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3620-0	Loratadine	10 in 1 BOTTLE	TABLET	10	3
50090-3620-1	Loratadine	20 in 1 BOTTLE, PLASTIC	TABLET	20	3
50090-3620-3	Loratadine	15 in 1 BOTTLE, PLASTIC	TABLET	15	3
50090-3620-4	Loratadine	30 in 1 BOTTLE, PLASTIC	TABLET	30	3
50090-3620-5	Loratadine	90 in 1 BOTTLE, PLASTIC	TABLET	90	3
50090-3620-6	Loratadine	7 in 1 BOTTLE, PLASTIC	TABLET	7	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3620	LORATADINE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 6 package rows	20190430_eb7196aa-898b-48d3-a6c7-8b52ff740b30.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	db815af2-4193-4fd9-a028-4a9d54325ca8	2026-06-18	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	WALMART INC. (see also Equate)	80958503-400c-422a-a641-e1a3d5a9a6a8	2026-04-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	c0e3057d-2dd2-de2b-e053-2995a90a1a1d	2026-03-05	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Safeway, Inc.	9e581ae1-d1e6-4038-86e8-fd0c5ab9878a	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Select Consumer Group	3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e	2025-12-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Bayer HealthCare LLC.	acf2d393-53d7-062f-e053-2995a90a0d60	2025-12-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE	Bayer HealthCare LLC.	dc65f7ec-bb83-7b29-e053-2995a90a99de	2025-12-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Family Dollar (FAMILY WELLNESS)	6b8d786e-2ee3-487f-bf7b-7dc738ea2fc9	2025-10-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Preferred Pharmaceuticals Inc.	836f566c-0296-408a-ad2a-6a77e1855218	2025-08-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Wal-itin	LORATADINE	Walgreens	6afa8056-1b7a-48a4-960c-92927169977e	2025-08-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Geri-Care Pharmaceutical Corp	b66f171a-7b95-b27a-e053-2a95a90a6009	2025-07-28	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy Relief	LORATADINE	WinCo Foods, LLC	706a59fa-3d15-4e6e-a38e-ad3f2ef46600	2025-04-08	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
CounterAct Allergy	LORATADINE	Melaleuca, Inc.	6b5d43ad-a709-4e0b-b91c-36ea0afe7221	2025-03-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	Bryant Ranch Prepack	e87aa69c-9ec6-482d-8e28-32542f6b9166	2025-02-04	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy relief	LORATADINE	A-S Medication Solutions	210fa77a-e33e-48c4-8228-b1cf3ccb7fa4	2025-01-30	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Claritin	LORATADINE TABLET	Lil' Drug Store Products, Inc.	f0e77162-c601-1a0f-e053-2a95a90ab714	2024-12-31	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	a282d209-1015-4570-b9df-7cc0a3753e37	2024-06-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	c5acd9d7-2f26-41c5-b369-2122251583ec	2024-05-17	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	QUALITY CHOICE (Chain Drug Marketing Association)	d47a5f1b-fb27-4618-a26e-a5eeabcd87f2	2024-05-16	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209
All Day Allergy Relief	LORATADINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7eac9202-bd4c-4550-a257-2b8195a0dbcd	2023-11-29	Warnings	Exact identifier application applno (ANDA): 075209 application number: ANDA075209

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
311372	loratadine 10 MG 24HR Oral Tablet	PSN	eb7196aa-898b-48d3-a6c7-8b52ff740b30	3
311372	loratadine 10 MG Oral Tablet	SCD	eb7196aa-898b-48d3-a6c7-8b52ff740b30	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	eb7196aa-898b-48d3-a6c7-8b52ff740b30	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3620-5	50090362005	90 TABLET in 1 BOTTLE, PLASTIC (50090-3620-5)	90 tablet	2016-02-01	0000-00-00	No	No	Current