Loratadine

Product NDC: 50090-0838
11-digit product format: 500900838
Labeler code: 50090
Product ID: 50090-0838_9ffc1763-9de3-4300-8e9b-6314c59027dd
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA076471
Marketing category: ANDA
Marketing start: 2005-01-24
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0838		I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-0	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-1	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-3	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-4	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-5	I	Inactivated by FDA	2026-08-17
excluded package	package	50090-0838	50090-0838-6	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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0838-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0838-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0838-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0838-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0838-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0838-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0838-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0838-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0838-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0838-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0838-6	`0efc9e666f02…`	`f202fb6c5f17…`

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
A076471-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2006-02-14

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	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50090-0838-0	Loratadine Tablet 10 mg
50090-0838-1	Loratadine Tablet 10 mg
50090-0838-3	Loratadine Tablet 10 mg
50090-0838-4	Loratadine Tablet 10 mg
50090-0838-5	Loratadine Tablet 10 mg
50090-0838-6	Loratadine Tablet 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0838-0	Loratadine	10 in 1 BOTTLE	TABLET	10	12
50090-0838-1	Loratadine	20 in 1 BOTTLE	TABLET	20	12
50090-0838-3	Loratadine	15 in 1 BOTTLE	TABLET	15	12
50090-0838-4	Loratadine	30 in 1 BOTTLE	TABLET	30	12
50090-0838-5	Loratadine	90 in 1 BOTTLE	TABLET	90	12
50090-0838-6	Loratadine	7 in 1 BOTTLE	TABLET	7	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0838-0	EA - Each	50090-0838	16941f83-c16e-4e55-8909-52ec9f4346c0	1	2018-10-11
50090-0838-1	EA - Each	50090-0838	ef3975af-88af-4879-8cf9-d846182cefcf	1	2018-10-11
50090-0838-3	EA - Each	50090-0838	5c04ea3f-6a0f-4f6d-b2d9-9d1248b6b240	1	2018-10-11
50090-0838-4	EA - Each	50090-0838	298b86a0-158e-43bd-a17a-e9ebfe408686	1	2018-10-11
50090-0838-5	EA - Each	50090-0838	89d04a35-9b65-4590-b453-511795851e03	1	2018-10-11
50090-0838-6	EA - Each	50090-0838	a3ac52be-36db-48e6-bcc9-c0c730b90214	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0838	LORATADINE TABLET [A-S MEDICATION SOLUTIONS]	12	Legacy NDC, 6 package rows	20200122_04a49370-7617-4097-9921-75cbd9fc4420.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Apotex Corp.	679164cc-7505-7ed4-13fe-87f06cb777d8	2025-09-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031fc3e5-b5eb-447c-e063-6294a90a13b5	2023-08-17	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy Relief	LORATADINE	Allegiant Health	0991388a-2eb8-4913-9efc-adf411eddf3a	2018-11-08	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471

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
311372	loratadine 10 MG 24HR Oral Tablet	PSN	04a49370-7617-4097-9921-75cbd9fc4420	12
311372	loratadine 10 MG Oral Tablet	SCD	04a49370-7617-4097-9921-75cbd9fc4420	12
311372	loratadine 10 MG 24 HR Oral Tablet	SY	04a49370-7617-4097-9921-75cbd9fc4420	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0838-0	50090083800	10 TABLET in 1 BOTTLE (50090-0838-0)	10 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0838-1	50090083801	20 TABLET in 1 BOTTLE (50090-0838-1)	20 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0838-3	50090083803	15 TABLET in 1 BOTTLE (50090-0838-3)	15 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0838-4	50090083804	30 TABLET in 1 BOTTLE (50090-0838-4)	30 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0838-5	50090083805	90 TABLET in 1 BOTTLE (50090-0838-5)	90 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0838-6	50090083806	7 TABLET in 1 BOTTLE (50090-0838-6)	7 tablet	2014-11-28	0000-00-00	No	No	Current