Loratadine

Product NDC: 45802-650
11-digit product format: 458020650
Labeler code: 45802
Product ID: 45802-650_497be46d-b620-41ae-bac0-95ef0bd94fe4
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076301
Marketing category: ANDA
Marketing start: 2008-10-15
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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`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
Brand name suffix: antihistamine
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
c72d8a30-520e-4d25-8f02-0c891e070a1a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45802-650-65	Loratadineantihistamine	1 in 1 CARTON	TABLET	1	10
45802-650-65	Loratadineantihistamine	30 in 1 BOTTLE	TABLET	30	10
45802-650-75	Loratadineantihistamine	90 in 1 BOTTLE	TABLET	90	10
45802-650-75	Loratadineantihistamine	1 in 1 CARTON	TABLET	1	10
45802-650-78	Loratadineantihistamine	100 in 1 BOTTLE	TABLET	100	10
45802-650-78	Loratadineantihistamine	1 in 1 CARTON	TABLET	1	10
45802-650-87	Loratadineantihistamine	1 in 1 CARTON	TABLET	1	10
45802-650-87	Loratadineantihistamine	300 in 1 BOTTLE	TABLET	300	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-650-65	EA - Each	45802-650	2be54e45-0384-4ce9-95be-a3d9c2d051b9	1	2012-07-24
45802-650-78	EA - Each	45802-650	9595d39f-57b3-4c72-a349-5e7bf613881b	1	2012-07-24
45802-650-87	EA - Each	45802-650	a7cf4204-74e4-4e42-b2ff-961de1024e5e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [BRYANT RANCH PREPACK]	1000
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE TABLET [H.J. HARKINS COMPANY, INC.]	5
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LORATADINE TABLET [PHYSICIANS TOTAL CARE, INC.]	4
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE TABLET [DIRECT RX]	3
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE TABLET [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE TABLET [DIRECT RX]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE TABLET [DIRECT RX]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE TABLET [DIRECT RX]	3
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-650	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PADAGIS ISRAEL PHARMACEUTICALS LTD]	8	Current NDC, Legacy NDC, 8 package rows	20250416_c72d8a30-520e-4d25-8f02-0c891e070a1a.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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	fc63689e-e449-ca8f-e053-6394a90a54a2	2025-02-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	54b37bcc-a8b0-0c17-e054-00144ff8d46c	2025-01-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
foster and thrive allergy relief	LORATADINE	Strategic Sourcing Services LLC	aff1ab34-51b0-488c-931e-c95aad226572	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good neighbor pharmacy loratadine	LORATADINE	Amerisource Bergen	9dda0f0b-fbab-47ee-8db8-95bd126fc61c	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
exchange select allergy relief	LORATADINE	Army & Air Force Exchange Service	ea5622d9-4e71-4a1f-9200-6b4cecac1215	2024-12-02	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	9cc3d50a-81ce-4c9d-9721-209169a332e0	2024-08-21	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	Meijer Distribution Inc	9261a02b-db43-462f-9f06-fb5624070e20	2024-08-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	a2c92766-df4e-4414-9c42-e18bcf9db6b4	2024-04-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	c288d849-59c9-4883-aac4-bae54acee8ac	2024-03-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
members mark allergy relief	LORATADINE	Sam's West Inc	95c2b45a-d0e5-467c-aad4-7bbb6c9a5204	2024-03-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
equate allergy relief	LORATADINE	Wal-Mart Stores Inc	dd36dc43-a9b7-4cda-86e0-9283d996a60a	2022-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
welby all day allergy relief	LORATADINE	Aldi, Inc	efe2fa11-8115-4d33-bb32-8e2509839ef4	2021-06-22	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	8ffe2faf-3253-4121-a069-6f46e319c6f0	2020-05-13	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301

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	1203981a-becd-4854-810d-b6d8842b5bd2	23
311372	loratadine 10 MG Oral Tablet	SCD	1203981a-becd-4854-810d-b6d8842b5bd2	23
311372	loratadine 10 MG 24 HR Oral Tablet	SY	1203981a-becd-4854-810d-b6d8842b5bd2	23
311372	loratadine 10 MG 24HR Oral Tablet	PSN	039f144b-891b-4ab0-e063-6394a90aa4c8	12
311372	loratadine 10 MG Oral Tablet	SCD	039f144b-891b-4ab0-e063-6394a90aa4c8	12
311372	loratadine 10 MG 24 HR Oral Tablet	SY	039f144b-891b-4ab0-e063-6394a90aa4c8	12
311372	loratadine 10 MG 24HR Oral Tablet	PSN	775885f9-0580-4eca-94d8-44fce1dcdccd	11
311372	loratadine 10 MG Oral Tablet	SCD	775885f9-0580-4eca-94d8-44fce1dcdccd	11
311372	loratadine 10 MG 24 HR Oral Tablet	SY	775885f9-0580-4eca-94d8-44fce1dcdccd	11
311372	loratadine 10 MG 24HR Oral Tablet	PSN	c72d8a30-520e-4d25-8f02-0c891e070a1a	10
311372	loratadine 10 MG Oral Tablet	SCD	c72d8a30-520e-4d25-8f02-0c891e070a1a	10
311372	loratadine 10 MG 24 HR Oral Tablet	SY	c72d8a30-520e-4d25-8f02-0c891e070a1a	10
311372	loratadine 10 MG 24HR Oral Tablet	PSN	8d3f03d9-6ae1-46d8-a4f8-c620af029c61	9
311372	loratadine 10 MG Oral Tablet	SCD	8d3f03d9-6ae1-46d8-a4f8-c620af029c61	9
311372	loratadine 10 MG 24 HR Oral Tablet	SY	8d3f03d9-6ae1-46d8-a4f8-c620af029c61	9
311372	loratadine 10 MG 24HR Oral Tablet	PSN	f3d05276-21bd-419d-8dba-07ce278d3375	8
311372	loratadine 10 MG Oral Tablet	SCD	f3d05276-21bd-419d-8dba-07ce278d3375	8
311372	loratadine 10 MG 24 HR Oral Tablet	SY	f3d05276-21bd-419d-8dba-07ce278d3375	8
311372	loratadine 10 MG 24HR Oral Tablet	PSN	e9b87f79-ebed-4677-8e50-00cb4282ee56	7
311372	loratadine 10 MG Oral Tablet	SCD	e9b87f79-ebed-4677-8e50-00cb4282ee56	7
311372	loratadine 10 MG 24 HR Oral Tablet	SY	e9b87f79-ebed-4677-8e50-00cb4282ee56	7
311372	loratadine 10 MG 24HR Oral Tablet	PSN	54b37bcc-a8b0-0c17-e054-00144ff8d46c	6
311372	loratadine 10 MG Oral Tablet	SCD	54b37bcc-a8b0-0c17-e054-00144ff8d46c	6
311372	loratadine 10 MG 24 HR Oral Tablet	SY	54b37bcc-a8b0-0c17-e054-00144ff8d46c	6
311372	loratadine 10 MG 24HR Oral Tablet	PSN	581dddb2-a731-4b9f-9fe9-f5ed7edc8394	5
311372	loratadine 10 MG 24HR Oral Tablet	PSN	a2c92766-df4e-4414-9c42-e18bcf9db6b4	5
311372	loratadine 10 MG Oral Tablet	SCD	a2c92766-df4e-4414-9c42-e18bcf9db6b4	5
311372	loratadine 10 MG Oral Tablet	SCD	581dddb2-a731-4b9f-9fe9-f5ed7edc8394	5
311372	loratadine 10 MG 24 HR Oral Tablet	SY	581dddb2-a731-4b9f-9fe9-f5ed7edc8394	5
311372	loratadine 10 MG 24 HR Oral Tablet	SY	a2c92766-df4e-4414-9c42-e18bcf9db6b4	5
311372	loratadine 10 MG 24HR Oral Tablet	PSN	18a78715-0096-4396-bf88-e3bf9f4d4017	4
311372	loratadine 10 MG Oral Tablet	SCD	18a78715-0096-4396-bf88-e3bf9f4d4017	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	18a78715-0096-4396-bf88-e3bf9f4d4017	4
311372	loratadine 10 MG 24HR Oral Tablet	PSN	fc63689e-e449-ca8f-e053-6394a90a54a2	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	3579972e-1a80-4fda-9dac-cb1ca278cabe	3
311372	loratadine 10 MG Oral Tablet	SCD	3579972e-1a80-4fda-9dac-cb1ca278cabe	3
311372	loratadine 10 MG Oral Tablet	SCD	fc63689e-e449-ca8f-e053-6394a90a54a2	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	3579972e-1a80-4fda-9dac-cb1ca278cabe	3
311372	loratadine 10 MG 24 HR Oral Tablet	SY	fc63689e-e449-ca8f-e053-6394a90a54a2	3
311372	loratadine 10 MG 24HR Oral Tablet	PSN	a11b1e64-d4aa-4a5d-84fa-85b4b133de71	2
311372	loratadine 10 MG Oral Tablet	SCD	a11b1e64-d4aa-4a5d-84fa-85b4b133de71	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	a11b1e64-d4aa-4a5d-84fa-85b4b133de71	2
311372	loratadine 10 MG 24HR Oral Tablet	PSN	fa5ddd82-33ba-4cc8-a13f-1a866299367e	1
311372	loratadine 10 MG Oral Tablet	SCD	fa5ddd82-33ba-4cc8-a13f-1a866299367e	1
311372	loratadine 10 MG 24 HR Oral Tablet	SY	fa5ddd82-33ba-4cc8-a13f-1a866299367e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-650-65	45802065065	1 BOTTLE in 1 CARTON (45802-650-65) / 30 TABLET in 1 BOTTLE	1 bottle	2008-10-15	0000-00-00	No	No	Current
45802-650-75	45802065075	1 BOTTLE in 1 CARTON (45802-650-75) / 90 TABLET in 1 BOTTLE	1 bottle	2023-09-15	2026-12-31	No	No	Historical
45802-650-78	45802065078	1 BOTTLE in 1 CARTON (45802-650-78) / 100 TABLET in 1 BOTTLE	1 bottle	2009-10-07	0000-00-00	No	No	Current
45802-650-87	45802065087	1 BOTTLE in 1 CARTON (45802-650-87) / 300 TABLET in 1 BOTTLE	1 bottle	2008-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Tablets, 10 mg Drug Facts	PD-Rx Pharmaceuticals, Inc.	2026-02-26	HUMAN OTC DRUG LABEL	12
Loratadine Tablets, 10 mg Drug Facts	PD-Rx Pharmaceuticals, Inc.	2026-02-26	HUMAN OTC DRUG LABEL	11
Perrigo Loratadine Tablets, 10 mg Drug Facts	NCS HealthCare of KY, LLC dba Vangard Labs	2025-12-22	HUMAN OTC DRUG LABEL	8
Perrigo Loratadine Tablets, 10 mg Drug Facts	A-S Medication Solutions	2025-12-06	HUMAN OTC DRUG LABEL	23
Perrigo Loratadine Tablets, 10 mg Drug Facts	Padagis Israel Pharmaceuticals Ltd	2025-09-12	HUMAN OTC DRUG LABEL	10
Perrigo Loratadine Tablets, 10 mg Drug Facts	A-S Medication Solutions	2025-04-04	HUMAN OTC DRUG LABEL	3
Perrigo Loratadine Tablets, 10 mg Drug Facts	Bryant Ranch Prepack	2025-04-03	HUMAN OTC DRUG LABEL	3
Perrigo Loratadine Tablets, 10 mg Drug Facts	NuCare Pharmaceuticals,Inc.	2025-02-05	HUMAN OTC DRUG LABEL	3
Perrigo Loratadine Tablets, 10 mg Drug Facts	NuCare Pharmaceuticals,Inc.	2025-01-09	HUMAN OTC DRUG LABEL	6
Perrigo Loratadine Tablets, 10 mg Drug Facts	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-23	HUMAN OTC DRUG LABEL	9
Perrigo Loratadine Tablets, 10 mg Drug Facts	Preferred Pharmaceuticals Inc.	2024-04-11	HUMAN OTC DRUG LABEL	1
Perrigo Loratadine Tablets, 10 mg Drug Facts	Aphena Pharma Solutions - Tennessee, LLC	2024-04-09	HUMAN OTC DRUG LABEL	5
LORATADINE	DirectRx	2023-09-11	HUMAN OTC DRUG LABEL	5
Perrigo Loratadine Tablets, 10 mg Drug Facts	REMEDYREPACK INC.	2023-08-11	HUMAN OTC DRUG LABEL	5
Perrigo Loratadine Tablets, 10 mg Drug Facts	REMEDYREPACK INC.	2023-08-03	HUMAN OTC DRUG LABEL	17
Perrigo Loratadine Tablets, 10 mg Drug Facts	REMEDYREPACK INC.	2023-04-17	HUMAN OTC DRUG LABEL	14
Perrigo Loratadine Tablets, 10 mg Drug Facts	Proficient Rx LP	2022-04-01	HUMAN OTC DRUG LABEL	7
Perrigo Loratadine Tablets, 10 mg Drug Facts	Bryant Ranch Prepack	2022-02-08	HUMAN PRESCRIPTION DRUG LABEL	1001
Loratadine Tablets, 10 mg Drug Facts	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-03-19	HUMAN OTC DRUG LABEL	2
Perrigo Loratadine Tablets, 10 mg Drug Facts	Lake Erie Medical DBA Quality Care Products LLC	2019-10-30	HUMAN OTC DRUG LABEL	4