Loratadine

Product NDC: 50268-489
11-digit product format: 502680489
Labeler code: 50268
Product ID: 50268-489_ed854db7-e859-fb08-e053-2a95a90aaf92
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA208314
Marketing category: ANDA
Marketing start: 2019-05-28
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50268-489		D	Discontinued by firm		2026-08-07
excluded package	package	50268-489	50268-489-15	D	Discontinued by firm		2026-08-07

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
A208314-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2018-04-16

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	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208314-001	LORATADINE	10MG	TABLET / ORAL	2018-04-16	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-489-11	EA - Each	50268-489	69c13423-4e0b-4359-96db-cb04476f0a6e	1	2019-11-12
50268-489-15	EA - Each	50268-489	3993552f-ae5e-4bb9-87c0-890dec9fb4cc	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-489	LORATADINE TABLET [AVPAK]	4	Legacy NDC	20240110_89f7abee-eab9-fe82-e053-2995a90a71eb.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	KROGER COMPANY	b96831f5-5e75-c526-e053-2995a90a36ad	2026-05-04	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
CONTAC Allergy	LORATADINE	Vespyr Brands LLC	4587a61d-139e-2a5b-e063-6394a90a1311	2026-05-01	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc.	7ca5050a-328a-4aff-8954-58f092e3ed6b	2026-04-21	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	CVS Pharmacy, Inc.	3937f769-e8e2-4b32-8338-21b0a74a8697	2026-03-20	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
AMAZON BASIC CARE ALLERGY RELIEF	LORATADINE	Amazon.com Services LLC	113da68e-f658-082a-e063-6294a90ad929	2026-03-18	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Aurobindo Pharma Limited	4f4ffb72-f4e8-4617-8bc5-61e6de488a2d	2025-11-12	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	A-S Medication Solutions	c84c2696-0d55-48a2-9d32-ca6c9bc57aa2	2025-11-11	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	A-S Medication Solutions	26c19e5b-7288-41a2-baaf-b4af19630140	2025-11-10	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
365 Whole Foods Market Loratadine	LORATADINE	Whole Foods Market, Inc.	bba4e7c8-db8e-4522-915c-48ee809e3bce	2025-06-11	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Major Pharmaceuticals	98e41ae1-677a-4583-9a0a-edba29ebbc30	2024-06-29	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	WALGREEN CO.	c016aad8-df83-99b0-e053-2a95a90a49cf	2024-06-24	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Cardinal Health	c96dd1c9-85a0-0792-e053-2a95a90a2264	2024-06-14	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
ALLERGY RELIEF 10mg	LORATADINE	YYBA CORP	6103cf98-40b1-4d27-8eb7-6f6a06949730	2024-01-03	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Chain Drug Consortium, LLC	21199958-ac67-4f72-8a8c-4d7d31fa9da4	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	McLane Company, Inc.	f988f9fb-463d-4aaa-b83d-54a3b114e570	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Aurohealth LLC	839e2e03-9ebb-4a44-b753-fb174bd36115	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Winco Foods, LLC.	2a6cf697-0084-4522-bc89-b3e0f96a598d	2022-08-17	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	BluePoint Laboratories	adc506ed-7a7a-facc-e053-2a95a90ae147	2022-06-20	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Aurohealth LLC	c6bfb54a-04d8-41c1-9fa9-5d4bae0a66d1	2022-06-18	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314
Loratadine	LORATADINE	Aurohealth LLC	196da80c-3dbb-40c7-ac93-8a57d6acb1c3	2020-08-13	Warnings	Exact identifier application applno (ANDA): 208314 application number: ANDA208314

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-489-15	50268048915	50 BLISTER PACK in 1 BOX (50268-489-15) > 1 TABLET in 1 BLISTER PACK (50268-489-11)	50 blister pack	2019-05-28	0000-00-00	No	No	Current