Loratadine

Product NDC: 68071-3596
11-digit product format: 680713596
Labeler code: 68071
Product ID: 68071-3596_4ece9297-a72e-a420-e063-6394a90ab367
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210722
Marketing category: ANDA
Marketing start: 2020-01-01
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210722-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2019-12-23

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1

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
311372	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
16f00a3a-0777-f70c-e063-6294a90a71c9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3596-3	Loratadine	30 in 1 BOTTLE	TABLET	30	3
68071-3596-6	Loratadine	60 in 1 BOTTLE	TABLET	60	3
68071-3596-9	Loratadine	90 in 1 BOTTLE	TABLET	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3596	LORATADINE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 3 package rows	20240820_16f00a3a-0777-f70c-e063-6294a90a71c9.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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ValuMeds Allergy Relief	LORATADINE	Cabinet Health P.B.C.	7a67f879-9df9-4536-8fd5-4b9aed05fb47	2025-02-28	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Advanced Rx LLC	e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d	2025-02-25	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
LORATADINE	LORATADINE	AMZ789 LLC	db71197e-d633-644d-e053-2a95a90a261d	2025-01-08	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Loratadine	LORATADINE	Spirit Pharmaceuticals LLC	af0cdab2-27a4-5f30-e053-2a95a90a5e71	2024-12-13	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
24 / 7 Life Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	efd0703f-f069-566e-e053-2995a90a74e4	2024-07-22	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Non-Drowsy Allergy Relief, 24-7 Life	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031ecc85-8324-4505-e063-6294a90a580b	2024-04-10	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
XL - 3 Allergy	XL - 3 ALLERGY	Selder, S.A. de C.V.	059a6e72-888e-4cb3-8722-4c3acbd6b4b0	2024-04-10	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
LORATADINE ALLERGY RELIEF 10mg	LORATADINE	YYBA CORP	dcb63e1b-d499-2e84-e053-2995a90af5c7	2024-01-03	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	AMERIFOODS TRADING COMPANY	f6ce5292-f698-dd2f-e053-6394a90ad74a	2023-11-02	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	FSA STORE INC.	ec6b31f3-ee68-1fbc-e053-2a95a90a05aa	2023-01-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
LORATADINE	LORATADINE	Camber Consumer Care Inc	1e92f77f-d4ba-4f34-96f9-daf878b4ea6a	2022-12-06	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	AAA PHARMACEUTICAL, INC.	9c8535e3-6a60-4640-b37e-a2260936d9af	2022-04-21	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	DISCOUNT DRUG MART	c29bf35f-1f19-c3c9-e053-2995a90ac1b6	2021-07-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	HARRIS TEETER	b8f67f52-906e-c7a8-e053-2995a90a5cbd	2021-04-29	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE 10MG	First Aid Direct	3a580dc7-ff09-462c-9b18-205105349035	2020-11-12	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	Marc Glassman, Inc.	717ccb47-e13c-4464-b6e6-bea8f24d4663	2020-09-28	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722
Allergy Relief	LORATADINE	Allegiant Health	f0db3a13-43e6-4243-9a3a-7808ddd005e1	2020-06-16	Warnings	Exact identifier application applno (ANDA): 210722 application number: ANDA210722

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	16f00a3a-0777-f70c-e063-6294a90a71c9	3
311372	loratadine 10 MG Oral Tablet	SCD	16f00a3a-0777-f70c-e063-6294a90a71c9	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	16f00a3a-0777-f70c-e063-6294a90a71c9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3596-3	68071359603	30 TABLET in 1 BOTTLE (68071-3596-3)	30 tablet	2026-04-06	No	No	Current
68071-3596-6	68071359606	60 TABLET in 1 BOTTLE (68071-3596-6)	60 tablet	2024-04-25	No	No	Current
68071-3596-9	68071359609	90 TABLET in 1 BOTTLE (68071-3596-9)	90 tablet	2024-04-25	No	No	Current