Loratadine

Product NDC: 50090-1454
Requested package NDC: 50090-1454-0
11-digit product format: 500901454
Labeler code: 50090
Product ID: 50090-1454_06ab4a12-31b8-435c-9988-f2e1ca56003c
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077421
Marketing category: ANDA
Marketing start: 2010-11-24
Substance: LORATADINE
Active strength: 5 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077421-001	LORATADINE	1MG/ML	SYRUP / ORAL	2006-06-29	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692783	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0f6fe391-8709-40f0-8f52-e3357e6ea4f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1454-0	Loratadine	120 mL in 1 CARTON	SOLUTION	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1454-0	ML - Milliliter	50090-1454	9e45b0b2-f209-4dbf-bfaa-1fb834aff468	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1454	LORATADINE SOLUTION [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 1 package rows	20231210_0f6fe391-8709-40f0-8f52-e3357e6ea4f9.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 ndc (package): 50090-1454-0 ndc (product): 50090-1454 ndc11 (package): 50090145400

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
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	10
692783	loratadine 1 MG/ML Oral Solution	SCD	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	10
692783	loratadine 5 MG per 5 ML Oral Solution	SY	0f6fe391-8709-40f0-8f52-e3357e6ea4f9	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1454-0	50090145400	120 mL in 1 CARTON (50090-1454-0)	120 ml	2014-11-28	0000-00-00	No	No	Current