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

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 Identifiers#

Field, Values table
Field	Values
Unii	7AJO3BO7QN
Rxcui	311372

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 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 [PERRIGO NEW YORK INC]	2
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [UNIT DOSE SERVICES]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PERRIGO NEW YORK 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
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 MOIETY	7AJO3BO7QN	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINEANTIHISTAMINE ANTIHISTAMINE (LORATADINE) TABLET [REMEDYREPACK INC. ]	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

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	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	Aphena Pharma Solutions - Tennessee, LLC	2024-04-09	HUMAN OTC DRUG LABEL	5
Perrigo Loratadine Tablets, 10 mg Drug Facts	Proficient Rx LP	2022-04-01	HUMAN OTC DRUG LABEL	7
LORATADINE	DIRECT RX	2015-11-03	HUMAN OTC DRUG LABEL	3
Perrigo Loratadine Tablets, 10 mg Drug Facts	REMEDYREPACK INC.	2013-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
Drug Facts	Physicians Total Care, Inc.	2012-06-20	HUMAN OTC DRUG LABEL	4
Perrigo Loratadine Tablets, 10 mg Drug Facts	H.J. Harkins Company, Inc. \| Perrigo New York Inc	2012-04-24	HUMAN OTC DRUG LABEL	5
Perrigo Loratadine Tablets, 10 mg Drug Facts	Unit Dose Services	2009-10-15	HUMAN OTC DRUG LABEL	2

Loratadine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#