LORATADINE

Product NDC: 51316-503
Requested package NDC: 51316-503-04
11-digit product format: 513160503
Labeler code: 51316
Product ID: 51316-503_0df114fa-ae43-e77d-e063-6294a90a8c36
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: CVS PHARMACY, INC
Application: ANDA213294
Marketing category: ANDA
Marketing start: 2021-08-08
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
A213294-001	LORATADINE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2020-10-30

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	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213294-001	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2020-10-30	`a50c72e98297…`

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
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
7ed2aec0-4da7-4edc-9998-b96c67c82738	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51316-503-01	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-02	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-03	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-04	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-05	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-06	2023-02-09	Loratidine Orally Disintegrating Tablets, USP
51316-503-01	2023-01-30	Loratidine Orally Disintegrating Tablets, USP
51316-503-02	2023-01-30	Loratidine Orally Disintegrating Tablets, USP
51316-503-03	2023-01-30	Loratidine Orally Disintegrating Tablets, USP
51316-503-04	2023-01-30	Loratidine Orally Disintegrating Tablets, USP
51316-503-05	2023-01-30	Loratidine Orally Disintegrating Tablets, USP
51316-503-06	2023-01-30	Loratidine Orally Disintegrating Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51316-503-01	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	8
51316-503-01	LORATADINE	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	8
51316-503-02	LORATADINE	20 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	20	8
51316-503-02	LORATADINE	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2	8
51316-503-03	LORATADINE	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	8
51316-503-03	LORATADINE	30 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	30	8
51316-503-04	LORATADINE	40 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	40	8
51316-503-04	LORATADINE	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	8
51316-503-05	LORATADINE	50 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	50	8
51316-503-05	LORATADINE	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5	8
51316-503-06	LORATADINE	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6	8
51316-503-06	LORATADINE	60 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	60	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-503	LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC]	8	Current NDC, Legacy NDC, 12 package rows	20240102_7ed2aec0-4da7-4edc-9998-b96c67c82738.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allervarx	LORATADINE	Innovus Pharmaceuticals, Inc.	885e81ae-5ea3-4d14-8666-8c2698767014	2024-12-27	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	1704474a-9b99-de45-e063-6294a90ac59b	2024-06-24	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	9c168fbb-6668-4a9d-9c7e-d3441e60eb95	2024-05-07	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
Alavert Allergy	LORATADINE	Foundation Consumer Healthcare	15c3f848-fef6-433b-e063-6394a90abd2b	2024-05-01	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	CVS PHARMACY, INC	7ed2aec0-4da7-4edc-9998-b96c67c82738	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294 ndc (package): 51316-503-04 ndc (product): 51316-503 ndc11 (package): 51316050304
LORATADINE	LORATADINE	Strides Pharma Inc	16ab6610-ac99-4714-848d-9377c6bca459	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Tenshi Kaizen Pvt Ltd	c20b916d-7dd0-1a56-e053-2995a90a3c1b	2024-01-02	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Dr. Reddy's Laboratories Inc.	d707733d-1ee9-92d3-f5b2-3567b9c217c2	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294
LORATADINE	LORATADINE	Dr. Reddy's Laboratories Inc.	bb6af6a4-aec0-ddf5-57b7-063504ca8e1e	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213294 application number: ANDA213294

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	7ed2aec0-4da7-4edc-9998-b96c67c82738	8
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	7ed2aec0-4da7-4edc-9998-b96c67c82738	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-503-04	51316050304	4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	4 blister pack	2021-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratidine Orally Disintegrating Tablets, USP	CVS PHARMACY, INC \| Tenshi Kaizen Pvt Ltd	2024-01-02	HUMAN OTC DRUG LABEL	8