Loratadine

Product NDC: 71610-423
11-digit product format: 716100423
Labeler code: 71610
Product ID: 71610-423_c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076301
Marketing category: ANDA
Marketing start: 2018-12-06
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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 · 43 observed 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	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`f41ea6bd6efb…`

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: 2026-12-31

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
8ffe2faf-3253-4121-a069-6f46e319c6f0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-423-60	Loratadine	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-423-60	EA - Each	71610-423	a85897c9-4f60-4bb8-ae6c-3b32cb34dc7e	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-423	LORATADINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20200527_8ffe2faf-3253-4121-a069-6f46e319c6f0.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 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	fc63689e-e449-ca8f-e053-6394a90a54a2	2025-02-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	54b37bcc-a8b0-0c17-e054-00144ff8d46c	2025-01-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
foster and thrive allergy relief	LORATADINE	Strategic Sourcing Services LLC	aff1ab34-51b0-488c-931e-c95aad226572	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good neighbor pharmacy loratadine	LORATADINE	Amerisource Bergen	9dda0f0b-fbab-47ee-8db8-95bd126fc61c	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
exchange select allergy relief	LORATADINE	Army & Air Force Exchange Service	ea5622d9-4e71-4a1f-9200-6b4cecac1215	2024-12-02	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	9cc3d50a-81ce-4c9d-9721-209169a332e0	2024-08-21	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	Meijer Distribution Inc	9261a02b-db43-462f-9f06-fb5624070e20	2024-08-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	a2c92766-df4e-4414-9c42-e18bcf9db6b4	2024-04-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	c288d849-59c9-4883-aac4-bae54acee8ac	2024-03-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
members mark allergy relief	LORATADINE	Sam's West Inc	95c2b45a-d0e5-467c-aad4-7bbb6c9a5204	2024-03-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
equate allergy relief	LORATADINE	Wal-Mart Stores Inc	dd36dc43-a9b7-4cda-86e0-9283d996a60a	2022-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	8ffe2faf-3253-4121-a069-6f46e319c6f0	2020-05-13	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301 ndc (product): 71610-423
good sense allergy relief	LORATADINE	L. Perrigo Company	74bed4ad-5afe-4293-bef3-e0b9d5f64a29	2019-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301

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	8ffe2faf-3253-4121-a069-6f46e319c6f0	1
311372	loratadine 10 MG Oral Tablet	SCD	8ffe2faf-3253-4121-a069-6f46e319c6f0	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	8ffe2faf-3253-4121-a069-6f46e319c6f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-423-60	71610042360	90 TABLET in 1 BOTTLE (71610-423-60)	90 tablet	2020-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Allergy Drug Facts	Aphena Pharma Solutions - Tennessee, LLC	2020-05-13	HUMAN OTC DRUG LABEL	1