Loratadine

Product NDC: 59779-528
11-digit product format: 597790528
Labeler code: 59779
Product ID: 59779-528_a6cabd7d-4312-4e21-a04d-bc8bbeafbdfb
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA076134
Marketing category: ANDA
Marketing start: 2010-01-08
Substance: LORATADINE
Active strength: 10 mg/1
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
A076134-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-08-18

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	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`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	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
e63f082c-ff50-43ed-ad2c-598b352413e8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59779-528-21	Loratadine	10 in 1 BLISTER PACK	TABLET	10	4
59779-528-21	Loratadine	2 in 1 CARTON	TABLET	2	4
59779-528-31	Loratadine	10 in 1 BLISTER PACK	TABLET	10	4
59779-528-31	Loratadine	3 in 1 CARTON	TABLET	3	4
59779-528-37	Loratadine	120 in 1 BOTTLE	TABLET	120	4
59779-528-37	Loratadine	2 in 1 CARTON	TABLET	2	4
59779-528-38	Loratadine	365 in 1 BOTTLE	TABLET	365	4
59779-528-38	Loratadine	1 in 1 CARTON	TABLET	1	4
59779-528-43	Loratadine	45 in 1 BOTTLE	TABLET	45	4
59779-528-43	Loratadine	1 in 1 CARTON	TABLET	1	4
59779-528-56	Loratadine	1 in 1 CARTON	TABLET	1	4
59779-528-56	Loratadine	5 in 1 BLISTER PACK	TABLET	5	4
59779-528-60	Loratadine	1 in 1 CARTON	TABLET	1	4
59779-528-60	Loratadine	60 in 1 BOTTLE	TABLET	60	4
59779-528-69	Loratadine	10 in 1 BLISTER PACK	TABLET	10	4
59779-528-69	Loratadine	1 in 1 CARTON	TABLET	1	4
59779-528-93	Loratadine	30 in 1 BOTTLE	TABLET	30	4
59779-528-93	Loratadine	2 in 1 CARTON	TABLET	2	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE TABLET [CVS PHARMACY]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE TABLET [CVS PHARMACY]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE TABLET [CVS PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE TABLET [CVS PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE TABLET [CVS PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-528	LORATADINE TABLET [CVS PHARMACY]	4	Current NDC, Legacy NDC, 18 package rows	20211222_e63f082c-ff50-43ed-ad2c-598b352413e8.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Chain Drug Marketing Association Inc.	b4edf5b1-398d-405a-8a42-76044b31ebb7	2018-08-27	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	HEB	6703e4f3-e9b8-4c70-9085-3d6ac0d7fbda	2018-05-14	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	Premier Value	778a6979-ea47-4381-8c40-84b3c2325a7e	2018-01-11	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	LIDL US, LLC	11bc027c-d28d-45f0-a4cb-24a3834a6995	2018-01-09	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134

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	e63f082c-ff50-43ed-ad2c-598b352413e8	4
311372	loratadine 10 MG Oral Tablet	SCD	e63f082c-ff50-43ed-ad2c-598b352413e8	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	e63f082c-ff50-43ed-ad2c-598b352413e8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-528-21	59779052821	2 BLISTER PACK in 1 CARTON (59779-528-21) / 10 TABLET in 1 BLISTER PACK	2 blister pack	2010-01-08	0000-00-00	No	No	Current
59779-528-31	59779052831	3 BLISTER PACK in 1 CARTON (59779-528-31) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2010-01-08	0000-00-00	No	No	Current
59779-528-37	59779052837	2 BOTTLE in 1 CARTON (59779-528-37) / 120 TABLET in 1 BOTTLE	2 bottle	2010-01-08	0000-00-00	No	No	Current
59779-528-38	59779052838	1 BOTTLE in 1 CARTON (59779-528-38) / 365 TABLET in 1 BOTTLE	1 bottle	2010-01-08	0000-00-00	No	No	Current
59779-528-43	59779052843	1 BOTTLE in 1 CARTON (59779-528-43) / 45 TABLET in 1 BOTTLE	1 bottle	2010-01-08	0000-00-00	No	No	Current
59779-528-56	59779052856	1 BLISTER PACK in 1 CARTON (59779-528-56) / 5 TABLET in 1 BLISTER PACK	1 blister pack	2010-01-08	0000-00-00	No	No	Current
59779-528-60	59779052860	1 BOTTLE in 1 CARTON (59779-528-60) / 60 TABLET in 1 BOTTLE	1 bottle	2010-01-08	0000-00-00	No	No	Current
59779-528-69	59779052869	1 BLISTER PACK in 1 CARTON (59779-528-69) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2010-01-08	0000-00-00	No	No	Current
59779-528-93	59779052893	2 BOTTLE in 1 CARTON (59779-528-93) / 30 TABLET in 1 BOTTLE	2 bottle	2010-01-08	0000-00-00	No	No	Current