Loratadine

Product NDC: 50090-4316
Requested package NDC: 50090-4316-0
11-digit product format: 500904316
Labeler code: 50090
Product ID: 50090-4316_0f9cef9d-1d98-42dc-acfc-161793d43442
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA076301
Marketing category: ANDA
Marketing start: 2019-02-20
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4316	50090-4316-0	D	Discontinued by firm		2026-08-03

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-4316	50090-4316-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-4316	50090-4316-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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 · 41 observed 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	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4316-0	2023-02-07	C162847	48780-1	f386c64a-0ebd-0266-e053-dadaa90a7c1a	NorthStar RxLLC Loratadine Tablets Drug Facts
50090-4316-0	2023-01-30	C162847	48780-1	f386c64a-0ebd-0266-e053-dadaa90a7c1a	NorthStar RxLLC Loratadine Tablets Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4316-0	EA - Each	50090-4316	14760c51-d4c1-44d2-b912-292811a6e7b8	1	2022-07-06

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy relief	LORATADINE	Walgreen Company	41f8fc1d-2d14-48da-a233-23e9c11296d9	2026-07-23	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
dg health allergy relief	LORATADINE	Dolgencorp Inc	dfc4b065-1980-48ec-9c3e-aaa4a42214d3	2026-07-02	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
CareOne Allergy Relief 24 Hour	LORATADINE	American Sales Company	bbd5424f-fa5b-4955-8542-7011b19400ea	2026-07-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	Rite Aid Corporation	5d58ed7a-e40b-417f-a216-5ec6721d361b	2026-05-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	L. Perrigo Company	80e8a6e8-0c5f-4065-9545-112e146d25ee	2026-04-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	PD-Rx Pharmaceuticals, Inc.	039f144b-891b-4ab0-e063-6394a90aa4c8	2026-02-26	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	PD-Rx Pharmaceuticals, Inc.	775885f9-0580-4eca-94d8-44fce1dcdccd	2026-02-26	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	CVS Pharmacy	0038bc38-c205-4d8d-ab78-1abbcd76829e	2026-02-25	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Berkley and Jensen Allergy Relief	LORATADINE	BJWC	e981a0ef-08e9-4ac3-92a1-411217e0a251	2026-02-16	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Major Pharmaceuticals	60162446-4fa1-4ee3-ae20-19fadc2491ab	2026-02-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Allergy Relief	LORATADINE	Kroger Company	dac0b200-6b02-4c8a-b1dd-a4d5341dfb2d	2026-02-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Allergy Relief	LORATADINE	HyVee Inc	b6ee2b7f-8e01-4962-b28f-91e5cac85276	2026-01-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NCS HealthCare of KY, LLC dba Vangard Labs	f3d05276-21bd-419d-8dba-07ce278d3375	2025-12-22	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Major Pharmaceuticals	dee25423-377b-4b94-a4a8-0dfb8f51aaab	2025-12-08	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	A-S Medication Solutions	1203981a-becd-4854-810d-b6d8842b5bd2	2025-12-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
goodnow allergy relief	LORATADINE	Gobrands, Inc	352a1268-7f44-417d-a46a-f0cc2e944a26	2025-11-15	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	A-S Medication Solutions	0eade963-be64-4718-a370-7e78efb91fc4	2025-11-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	A-S Medication Solutions	6f82e0ab-2c01-4afb-8d0f-b0c06819d1b0	2025-11-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	A-S Medication Solutions	4cee60b6-b32b-47d0-aa00-a7ea1a7ed3cf	2025-11-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Padagis Israel Pharmaceuticals Ltd	c72d8a30-520e-4d25-8f02-0c891e070a1a	2025-09-12	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4316-0	50090431600	30 TABLET in 1 BOTTLE (50090-4316-0)	30 tablet	2019-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NorthStar RxLLC Loratadine Tablets Drug Facts	A-S Medication Solutions	2025-04-15	HUMAN OTC DRUG LABEL	10