LORATADINE

Product NDC: 51316-502
Requested package NDC: 51316-502-03
11-digit product format: 513160502
Labeler code: 51316
Product ID: 51316-502_28e49606-cbf6-7029-e063-6394a90ae3b7
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: CVS PHARMACY, INC
Application: ANDA212795
Marketing category: ANDA
Marketing start: 2021-12-31
Substance: LORATADINE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51316-502	51316-502-03	I	Inactivated by FDA		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51316-502	51316-502-03	I	Inactivated by FDA		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

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
4e74e322-7f6e-467c-96c0-9b531ddb429b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51316-502-01	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-02	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-03	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-04	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-05	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-06	2024-12-31	Loratadine Orally Disintegrating Tablets USP
51316-502-01	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-02	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-03	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-04	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-05	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-06	2024-07-30	Loratadine Orally Disintegrating Tablets USP
51316-502-01	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-02	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-03	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-04	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-05	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-06	2024-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-01	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-02	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-03	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-04	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-05	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-06	2023-02-09	Loratadine Orally Disintegrating Tablets USP
51316-502-01	2023-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-02	2023-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-03	2023-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-04	2023-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-05	2023-01-30	Loratadine Orally Disintegrating Tablets USP
51316-502-06	2023-01-30	Loratadine Orally Disintegrating Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51316-502-01	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-01	LORATADINE	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1	6
51316-502-02	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-02	LORATADINE	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2	6
51316-502-03	LORATADINE	3 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	3	6
51316-502-03	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-04	LORATADINE	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	6
51316-502-04	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-05	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-05	LORATADINE	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	5	6
51316-502-06	LORATADINE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10	6
51316-502-06	LORATADINE	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-502	LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC]	6	Current NDC, Legacy NDC, 12 package rows	20250101_4e74e322-7f6e-467c-96c0-9b531ddb429b.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 ndc (package): 51316-502-03 ndc (product): 51316-502 ndc11 (package): 51316050203
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
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	4e74e322-7f6e-467c-96c0-9b531ddb429b	6
672558	loratadine 5 MG Disintegrating Oral Tablet	SCD	4e74e322-7f6e-467c-96c0-9b531ddb429b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-502-03	51316050203	3 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2021-12-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Orally Disintegrating Tablets USP	CVS PHARMACY, INC \| Reed-Lane, Inc. \| Quality Packaging Specialists International, LLC \| Tenshi Kaizen Pvt Ltd	2024-12-31	HUMAN OTC DRUG LABEL	6