Loratadine Allergy Relief

Product NDC: 76420-330
Requested package NDC: 76420-330-11
11-digit product format: 764200330
Labeler code: 76420
Product ID: 76420-330_359e8af9-0b81-5837-e063-6394a90a58a1
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA076134
Marketing category: ANDA
Marketing start: 2017-11-01
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
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 Allergy Relief
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
332bda00-1350-2d33-e063-6394a90a8bd7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-330-01	Loratadine Allergy Relief	100 in 1 BOTTLE	TABLET	100	2
76420-330-03	Loratadine Allergy Relief	300 in 1 BOTTLE	TABLET	300	2
76420-330-05	Loratadine Allergy Relief	500 in 1 BOTTLE	TABLET	500	2
76420-330-10	Loratadine Allergy Relief	10 in 1 BOTTLE	TABLET	10	2
76420-330-11	Loratadine Allergy Relief	10 in 1 BLISTER PACK	TABLET	10	2
76420-330-20	Loratadine Allergy Relief	20 in 1 BOTTLE	TABLET	20	2
76420-330-30	Loratadine Allergy Relief	30 in 1 BOTTLE	TABLET	30	2
76420-330-31	Loratadine Allergy Relief	30 in 1 BLISTER PACK	TABLET	30	2
76420-330-60	Loratadine Allergy Relief	60 in 1 BOTTLE	TABLET	60	2
76420-330-90	Loratadine Allergy Relief	90 in 1 BOTTLE	TABLET	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-330	LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [ASCLEMED USA, INC.]	2	Current NDC, 10 package rows	20250523_332bda00-1350-2d33-e063-6394a90a8bd7.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE	Cardinal Health 107, LLC	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	2026-06-04	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
MEDIQUE Loradamed	LORATADINE	Sportpharm LLC	d6bf0e68-f87c-49ee-a15d-df7f5bfa6221	2026-04-24	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	PD-Rx Pharmaceuticals, Inc.	7127b39d-3686-4249-b720-43c02b4c4654	2026-03-19	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	a53e5635-8633-4c28-b04f-cdfb3d851e68	2026-02-19	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Green Guard 24 Hour Allergy Relief	LORATADINE	Unifirst First Aid Corporation	32092beb-c177-4b6b-afa4-b4b5d64621f4	2025-11-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Marlex Pharmaceuticals, Inc.	ec08a6ee-3d71-0fa9-e053-2995a90a9cb1	2025-11-18	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Asclemed USA, Inc.	332bda00-1350-2d33-e063-6394a90a8bd7	2025-05-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134 ndc (package): 76420-330-11 ndc (product): 76420-330 ndc11 (package): 76420033011
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	0be70365-57ee-4f2e-a30f-bdd5c292992d	2025-02-20	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	A-S Medication Solutions	baaf9c23-0b54-46a2-8aec-13264479a6d7	2025-02-20	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	American Health Packaging	411f3692-99ff-49d7-8594-e6f404f5861f	2024-11-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Proficient Rx LP	a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb	2024-10-01	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	40914eeb-3a85-4691-9fb8-2df72ba1f709	2024-04-05	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	Bryant Ranch Prepack	94642b79-f91a-429f-87f4-dad326d4f3ed	2024-04-03	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	OHM LABORATORIES INC.	c35f2cc1-f76d-4824-b0a5-747bca0c3b85	2023-12-08	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Handy Solutions 24 Hour Allergy	LORATADINE	Navajo Manufacturing Company Inc.	67263031-9095-48f2-8b34-e589b28a7416	2023-03-15	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	SAFEWAY INC.	1092b8af-25f2-4c25-b3bc-5ffb14e96024	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	CVS Pharmacy	e63f082c-ff50-43ed-ad2c-598b352413e8	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	DISCOUNT DRUG MART	55d3ee36-116b-4ec6-b409-79d67a2b54ae	2018-09-14	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine Allergy Relief	LORATADINE	WinCo Foods, LLC	506a60e8-7fec-4bb0-babc-204058ae120f	2018-08-29	Warnings	Exact identifier application applno (ANDA): 076134 application number: ANDA076134
Loratadine	LORATADINE	Valu Merchandisers Company	0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8	2018-08-28	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	332bda00-1350-2d33-e063-6394a90a8bd7	2
311372	loratadine 10 MG Oral Tablet	SCD	332bda00-1350-2d33-e063-6394a90a8bd7	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	332bda00-1350-2d33-e063-6394a90a8bd7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-330-11	76420033011	10 TABLET in 1 BLISTER PACK (76420-330-11)	10 tablet	2025-04-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Allergy Relief	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-21	HUMAN OTC DRUG LABEL	2