Loratadine ODT

Product NDC: 49035-806
11-digit product format: 490350806
Labeler code: 49035
Product ID: 49035-806_3b02a6a4-b8f8-43b4-bf82-f5fd0007643f
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Wal-Mart Stores, Inc.
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
7679ee14-08aa-459c-9107-1a7144379962	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-806-09	Loratadine ODT	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	4
49035-806-09	Loratadine ODT	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	4
49035-806-03	Loratadine ODT	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	3
49035-806-03	Loratadine ODT	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-806-03	EA - Each	49035-806	29bc985c-e772-4aca-aede-61203edfa065	1	2025-07-08
49035-806-09	EA - Each	49035-806	82f9ee1c-b48a-40da-9eb3-a718601822af	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-806	LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20221108_f399f7ab-ab51-46ff-bce9-3014eb021930.zip
49035-806	LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250130_7679ee14-08aa-459c-9107-1a7144379962.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 ndc (product): 49035-806
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 ndc (product): 49035-806
Loratadine ODT	LORATADINE	Aurohealth LLC	1ba8e521-0b0f-419c-b7c3-fa9586f83f36	2022-11-03	Warnings	Exact identifier application applno (ANDA): 208477 application number: ANDA208477
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	f399f7ab-ab51-46ff-bce9-3014eb021930	4
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	f399f7ab-ab51-46ff-bce9-3014eb021930	4
311373	loratadine 10 MG 24HR Disintegrating Oral Tablet	PSN	7679ee14-08aa-459c-9107-1a7144379962	3
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	7679ee14-08aa-459c-9107-1a7144379962	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-806-03	49035080603	1 BLISTER PACK in 1 CARTON (49035-806-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2018-04-11	0000-00-00	No	No	Current
49035-806-09	49035080609	3 BLISTER PACK in 1 CARTON (49035-806-09) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 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	Wal-Mart Stores, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	2025-01-23	Human OTC Drug Label	3
Loratadine Orally Disintegrating Tablets USP 10 mg	Wal-Mart Stores, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	2022-11-04	Human OTC Drug Label	4