Loratadine ODT

Product NDC: 58602-830
11-digit product format: 586020830
Labeler code: 58602
Product ID: 58602-830_5c099ee7-0679-45af-ac3d-d8e77d12e809
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA208477
Marketing category: ANDA
Marketing start: 2018-04-11
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 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
A208477-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2018-04-11

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	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208477-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2018-04-11	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine ODT
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
311373	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
1ba8e521-0b0f-419c-b7c3-fa9586f83f36	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58602-830-83	Loratadine ODT	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		3
58602-830-83	Loratadine ODT	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-830	LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC]	3	Current NDC, Legacy NDC, 2 package rows	20221104_1ba8e521-0b0f-419c-b7c3-fa9586f83f36.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine ODT	LORATADINE	CVS Pharmacy, Inc.	37443f0d-bda0-4ddc-a2dd-f3daf495cb40	2025-03-17	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Wal-Mart Stores, Inc.	7679ee14-08aa-459c-9107-1a7144379962	2025-01-23	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	WALGREEN CO.	7556b959-3ff2-4489-ae06-67ef398c623c	2024-06-18	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
CHILDRENS LORATADINE ODT	LORATADINE	WALGREEN CO.	cd597728-35fb-4e43-85ea-84af802e1983	2024-05-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Better Living Brands, LLC	fad93257-bfcf-5e04-e053-6394a90a10a6	2023-09-25	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Amerisource Bergen	d2524455-b6c4-442b-b139-666a555c5298	2023-07-10	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Chain Drug Consortium, LLC	7674009d-492d-4005-a652-f12b91428c0d	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	DISCOUNT DRUG MART	b4a11eb4-cff8-4280-9dc9-757d51100354	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Ahold U.S.A., Inc,	092aec8d-57d5-4487-8e1a-b4b586bee7cf	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Wal-Mart Stores, Inc.	f399f7ab-ab51-46ff-bce9-3014eb021930	2022-11-04	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Aurohealth LLC	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477 ndc (product): 58602-830
Loratadine ODT	LORATADINE	Aurohealth LLC	9f44382f-c289-402d-bb98-ec5fa80fc25d	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Aurohealth LLC	8c119b12-f512-4207-b354-7244d1f9963a	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Rugby Laboratories	f59f3400-da77-4eb7-be02-842071d87fae	2022-10-06	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
Loratadine ODT	LORATADINE	Aurohealth LLC	a6e04fe7-23d3-47d7-9f18-5c4298fbc28b	2022-06-20	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477

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
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	3
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-830-83	58602083083	1 BLISTER PACK in 1 CARTON (58602-830-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2018-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Orally Disintegrating Tablets USP 10 mg	Aurohealth LLC \| Aurobindo Pharma Limited	2022-11-03	Human OTC Drug Label	3