Loratadine

Product NDC: 68084-248
11-digit product format: 680840248
Labeler code: 68084
Product ID: 68084-248_276fa85f-4a61-3308-e063-6294a90aeda4
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076134
Marketing category: ANDA
Marketing start: 2007-11-21
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`e64feba35796…`

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
411f3692-99ff-49d7-8594-e6f404f5861f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-248-01	Loratadine	100 in 1 BOX, UNIT-DOSE	TABLET	100		8
68084-248-11	Loratadine	1 in 1 BLISTER PACK	TABLET	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-248-01	EA - Each	68084-248	165b06ea-6df4-4705-ab8d-10bd222c107e	1	2012-07-24
68084-248-11	EA - Each	68084-248	951de69e-80c5-4d40-9701-de374b02ec8b	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-248	LORATADINE TABLET [AMERICAN HEALTH PACKAGING]	8	Current NDC, Legacy NDC, 2 package rows	20241123_411f3692-99ff-49d7-8594-e6f404f5861f.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 · 25 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
McKesson Loratadine	LORATADINE 10 MG	McKesson Medical Surgical	c6a3056e-792e-52a4-e053-2a95a90a8361	2025-10-23	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
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 ndc (product): 68084-248
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

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	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	12
311372	loratadine 10 MG Oral Tablet	SCD	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	12
311372	loratadine 10 MG 24 HR Oral Tablet	SY	64489b01-a4a7-4c6d-ac84-1dfbd1388d84	12
311372	loratadine 10 MG 24HR Oral Tablet	PSN	411f3692-99ff-49d7-8594-e6f404f5861f	8
311372	loratadine 10 MG Oral Tablet	SCD	411f3692-99ff-49d7-8594-e6f404f5861f	8
311372	loratadine 10 MG 24 HR Oral Tablet	SY	411f3692-99ff-49d7-8594-e6f404f5861f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-248-01	68084024801	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-248-01) / 1 TABLET in 1 BLISTER PACK (68084-248-11)	100 blister pack	2007-11-21	0000-00-00	No	No	Current
68084-248-11	68084024811	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Tablets, USP Antihistamine Drug Facts	Cardinal Health 107, LLC	2026-06-04	HUMAN OTC DRUG LABEL	13
Loratadine Tablets, USP Antihistamine Drug Facts	American Health Packaging	2024-11-21	HUMAN OTC DRUG LABEL	8