Loratadine

Product NDC: 68788-7291
11-digit product format: 687887291
Labeler code: 68788
Product ID: 68788-7291_6968b46b-fa63-4f8e-b01f-3be9dd45e177
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA077421
Marketing category: ANDA
Marketing start: 2019-01-22
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 5 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-7291		D	Discontinued by firm		2026-08-10
excluded package	package	68788-7291	68788-7291-1	D	Discontinued by firm		2026-08-10

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 · 4 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	68788-7291-1	`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	68788-7291-1	`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
A077421-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2006-06-29

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	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7291-1	ML - Milliliter	68788-7291	877eafea-3e74-4cee-a663-b73fdd13082f	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7291	LORATADINE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	6	Legacy NDC	20240627_80b899df-a426-46c6-92e6-348a868b1712.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	ATLANTIC BIOLOGICALS CORP.	999a1080-5bbd-4027-b6e7-a90a6941ee27	2026-02-26	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421
Loratadine	LORATADINE	Lannett Company, Inc.	069c4e75-1f9f-4ab5-9570-3d93d12c2a23	2025-06-19	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421
Loratadine	LORATADINE	NuCare Pharmaceuticals,Inc.	6d0c0948-9288-9bb8-e053-2a91aa0abf3a	2024-06-10	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421
Loratadine	LORATADINE	A-S Medication Solutions	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	2023-12-09	Warnings	Exact identifier application applno (ANDA): 077421 application number: ANDA077421

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
68788-7291-1	68788729101	120 mL in 1 CARTON (68788-7291-1)	120 ml	2019-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Loratadine Oral Solution	Preferred Pharmaceuticals Inc.	2024-06-25	HUMAN OTC DRUG LABEL	6