Loratadine

Product NDC: 68210-4126
Requested package NDC: 68210-4126-1
11-digit product format: 682104126
Labeler code: 68210
Product ID: 68210-4126_eea1dd7f-6cf4-880e-e053-2995a90adfdd
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: ANDA214684
Marketing category: ANDA
Marketing start: 2021-04-07
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68210-4126	68210-4126-1	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A214684-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2021-01-07

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	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68210-4126-1	2024-01-30	C162847	48780-1	1030e365-1991-111a-e063-dadaa90a10e2	Loratadine Tablets, 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4126-1	Loratadine	365 in 1 PACKAGE	TABLET	365		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4126	LORATADINE TABLET [SPIRIT PHARMACEUTICALS LLC]	3	Legacy NDC, 1 package rows	20221130_22adc4f4-e881-4253-8080-7ef49151055a.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	NuCare Pharmaceuticals, Inc.	569a35be-d653-181c-e063-6294a90a6eb9	2026-07-14	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Preferred Pharmaceuticals Inc	0a0d700d-bdba-4c90-a947-5d61d40ce4df	2026-05-28	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
ValuMeds Allergy Relief Loratadine	LORATADINE	Cabinet Health P.B.C.	43bc8e38-bd74-411c-b4fe-7d809d24ae46	2026-05-20	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Strategic Sourcing Services, LLC	a527f83a-4ae9-47b1-94e0-7ab3148b025f	2026-01-29	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Cabinet Health P.B.C.	8b090fa2-9535-456c-b14d-187a2873cdf7	2025-10-27	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
CVS Loratadine	LORATADINE	CVS Pharmacy	3d716988-da63-59e6-e063-6394a90a5b4b	2025-10-22	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Nuvicare-Allergy Relief Loratadine Tablets, 10 mg	LORATADINE	NUVICARE LLC	023a46f0-8d1c-4f62-953d-3e6458a54f6e	2025-07-01	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Gencare-Allergy Relief Loratadine Tablets, 10 mg	LORATADINE	Pioneer Life Sciences, LLC	647dc957-4aee-48f6-bb77-e82d3b380e80	2025-06-30	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Gobrands, Inc	1d182bd6-ad72-4352-b983-407a48c317f0	2025-01-25	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb43cf-57a9-f189-e063-6294a90afd88	2024-12-31	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Exact identifier application applno (ANDA): 214684 application number: ANDA214684

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	22adc4f4-e881-4253-8080-7ef49151055a	3
311372	loratadine 10 MG Oral Tablet	SCD	22adc4f4-e881-4253-8080-7ef49151055a	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	22adc4f4-e881-4253-8080-7ef49151055a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4126-1	68210412601	365 TABLET in 1 PACKAGE (68210-4126-1)	365 tablet	2021-04-07	0000-00-00	No	No	Current