Loratadine

Product NDC: 48433-064
11-digit product format: 484330064
Labeler code: 48433
Product ID: 48433-064_4e5410fd-6d27-f0d2-e063-6394a90a016f
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA076154
Marketing category: ANDA
Marketing start: 2026-03-24
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A076154-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-08-20

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	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076154-001	LORATADINE	10MG	TABLET / ORAL	2003-08-20	`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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1

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
311372	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
14d1ecf5-d694-4ce0-87e4-df27f3f4d909	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-064-01	Loratadine	1 in 1 BLISTER PACK	TABLET	1		2
48433-064-20	Loratadine	100 in 1 CARTON	TABLET	100		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Safecor Health, LLC	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2026-03-31	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154 ndc (product): 48433-064
Loratadine	LORATADINE	Mylan Institutional Inc.	1fc9ddd1-393d-4fe2-a9e0-d192df7331db	2025-07-22	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154
Loratadine	LORATADINE	Mylan Pharmaceuticals Inc.	3b307aea-5a68-4c82-959a-cda4ffbd0a4a	2013-11-15	Warnings	Exact identifier application applno (ANDA): 076154 application number: ANDA076154

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	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2
311372	loratadine 10 MG Oral Tablet	SCD	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	14d1ecf5-d694-4ce0-87e4-df27f3f4d909	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-064-01	48433006401	1 in 1 BLISTER PACK					Historical
48433-064-20	48433006420	100 BLISTER PACK in 1 CARTON (48433-064-20) / 1 TABLET in 1 BLISTER PACK (48433-064-01)	100 blister pack	2026-03-24	No	No	Current