Loratadine

Product NDC: 72983-500
11-digit product format: 729830500
Labeler code: 72983
Product ID: 72983-500_0df0dfde-1f52-4769-e063-6394a90a2f92
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Tenshi Kaizen Pvt Ltd
Application: ANDA212795
Marketing category: ANDA
Marketing start: 2021-05-19
Substance: LORATADINE
Active strength: 5 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
A212795-001	LORATADINE	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-09-18

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
2026-02-19 14:30 UTC	2026-02	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212795-001	LORATADINE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-09-18	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 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
672558	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
c20b91e0-ef92-6f2f-e053-2a95a90a2a36	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72983-500-01	Loratadine	1 in 1 CARTON	TABLET	1		5
72983-500-01	Loratadine	10 in 1 BLISTER PACK	TABLET	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72983-500	LORATADINE TABLET [TENSHI KAIZEN PVT LTD]	5	Current NDC, Legacy NDC, 2 package rows	20240102_c20b91e0-ef92-6f2f-e053-2a95a90a2a36.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORATADINE	LORATADINE	CVS PHARMACY, INC	4e74e322-7f6e-467c-96c0-9b531ddb429b	2024-12-31	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795
Allervarx	LORATADINE	Innovus Pharmaceuticals, Inc.	ec4d1e77-6995-4228-8e63-a9ab6232dace	2024-12-27	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795
Loratadine	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b91e0-ef92-6f2f-e053-2a95a90a2a36	2024-01-02	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795 ndc (product): 72983-500
LORATADINE	LORATADINE	Strides Pharma Inc	a54cdbe9-32ec-45ca-948f-9cefbb8e3cbf	2024-01-02	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795
Loratadine	LORATADINE	Walgreens Company	8229ca40-31cf-3dbd-078d-364f5674cb21	2023-02-27	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795
Loratadine	LORATADINE	Dr. Reddy's Laboratories Inc.	9357186a-9452-e139-01d8-6b8c6f6a2c6b	2023-02-24	Warnings	Exact identifier application applno (ANDA): 212795 application number: ANDA212795

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
672558	loratadine 5 MG Disintegrating Oral Tablet	PSN	c20b91e0-ef92-6f2f-e053-2a95a90a2a36	5
672558	loratadine 5 MG Disintegrating Oral Tablet	SCD	c20b91e0-ef92-6f2f-e053-2a95a90a2a36	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72983-500-01	72983050001	1 BLISTER PACK in 1 CARTON (72983-500-01) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2021-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Orally Disintegrating Tablets USP	Tenshi Kaizen Pvt Ltd	2024-01-02	HUMAN OTC DRUG LABEL	5