Loratadine

Product NDC: 24385-540
11-digit product format: 243850540
Labeler code: 24385
Product ID: 24385-540_ba155366-479c-4de8-b02f-cc287131a60d
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Good Neighbor Pharmacy
Application: ANDA077153
Marketing category: ANDA
Marketing start: 2007-08-31
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	24385-540		I	Inactivated by FDA		2026-08-17
excluded package	package	24385-540	24385-540-53	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	24385-540-53	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	24385-540-53	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	24385-540-53	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	24385-540-53	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	24385-540-53	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	24385-540-53	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	24385-540-53	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	24385-540-53	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	24385-540-53	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	24385-540-53	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	24385-540-53	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	24385-540-53	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	24385-540-53	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	24385-540-53	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	24385-540-53	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	24385-540-53	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	24385-540-53	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	24385-540-53	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	24385-540-53	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	24385-540-53	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	24385-540-53	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	24385-540-53	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077153-001	LORATADINE REDIDOSE	LORATADINE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2007-04-11

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077153-001	LORATADINE REDIDOSE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-04-11	`e64feba35796…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24385-540-53	2020-01-31	C162847	48780-1	9d75b9d0-0f64-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24385-540-53	Loratadine	12 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	12		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24385-540-53	EA - Each	24385-540	a3a31b9d-3aff-404b-97d4-ad45b96c2ed5	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24385-540	LORATADINE TABLET, ORALLY DISINTEGRATING [GOOD NEIGHBOR PHARMACY]	1	Legacy NDC, 1 package rows	20121121_08bef2a7-c15f-4930-97c1-9d988e7b5181.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	LORATADINE	Ohm Laboratories Inc.	de3a7725-5d1b-4195-a9f8-43f92888997c	2021-04-06	Warnings	Exact identifier application applno (ANDA): 077153 application number: ANDA077153

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	08bef2a7-c15f-4930-97c1-9d988e7b5181	1
311373	loratadine 10 MG Disintegrating Oral Tablet	SCD	08bef2a7-c15f-4930-97c1-9d988e7b5181	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
24385-540-53	24385054053	12 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Good Neighbor Pharmacy \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2012-10-31	HUMAN OTC DRUG LABEL	1