Clarithromycin

Product NDC: 0781-1962
11-digit product format: 007811962
Labeler code: 0781
Product ID: 0781-1962_a18fa357-b294-48b9-aabe-dad7d6259ba3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065136
Marketing category: ANDA
Marketing start: 2005-08-25
Substance: CLARITHROMYCIN
Active strength: 500 mg/1
Pharmacologic classes: Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLARITHROMYCIN	500 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	H1250JIK0A
Rxcui	197516, 197517

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2	Product name	7	20221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-1962-01	Clarithromycin	100 in 1 BOTTLE	TABLET	100	23
0781-1962-05	Clarithromycin	500 in 1 BOTTLE	TABLET	500	23
0781-1962-31	Clarithromycin	30 in 1 BOTTLE	TABLET	30	23
0781-1962-60	Clarithromycin	60 in 1 BOTTLE	TABLET	60	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1962-60	EA - Each	0781-1962	62606abb-9b9c-4257-94dc-2d661592cab8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CLARITHROMYCIN TABLET [SANDOZ INC]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CLARITHROMYCIN TABLET [SANDOZ INC]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [SANDOZ INC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [SANDOZ INC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [SANDOZ INC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]	15
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]	3
clarithromycin	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
clarithromycin	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-1962	CLARITHROMYCIN TABLET [SANDOZ INC]	23	Current NDC, Legacy NDC, 4 package rows	20231102_b98b02bb-2609-49a0-b29f-e5911aa0cbc1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H1250JIK0A	CLARITHROMYCIN	81103-11-9	CLARITHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197517	clarithromycin 500 MG Oral Tablet	PSN	0be243c6-de02-45dd-8210-cab1bbc8dfa7	29
197517	clarithromycin 500 MG Oral Tablet	SCD	0be243c6-de02-45dd-8210-cab1bbc8dfa7	29
197516	clarithromycin 250 MG Oral Tablet	PSN	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197517	clarithromycin 500 MG Oral Tablet	PSN	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197516	clarithromycin 250 MG Oral Tablet	SCD	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197517	clarithromycin 500 MG Oral Tablet	SCD	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197517	clarithromycin 500 MG Oral Tablet	PSN	adba78c2-9e51-4bed-8c6a-6f977f79c40c	8
197517	clarithromycin 500 MG Oral Tablet	SCD	adba78c2-9e51-4bed-8c6a-6f977f79c40c	8
197517	clarithromycin 500 MG Oral Tablet	PSN	3fdb8746-395f-1123-e054-00144ff88e88	7
197517	clarithromycin 500 MG Oral Tablet	SCD	3fdb8746-395f-1123-e054-00144ff88e88	7
197517	clarithromycin 500 MG Oral Tablet	PSN	27e02b77-4332-49e0-8d0c-a072cf5dff92	6
197517	clarithromycin 500 MG Oral Tablet	SCD	27e02b77-4332-49e0-8d0c-a072cf5dff92	6
197517	clarithromycin 500 MG Oral Tablet	PSN	f98aacb4-2f01-3e94-e053-6294a90a9aa0	4
197517	clarithromycin 500 MG Oral Tablet	PSN	d22bd12c-737b-4aab-e053-2995a90aff60	4
197517	clarithromycin 500 MG Oral Tablet	SCD	f98aacb4-2f01-3e94-e053-6294a90a9aa0	4
197517	clarithromycin 500 MG Oral Tablet	SCD	d22bd12c-737b-4aab-e053-2995a90aff60	4
197517	clarithromycin 500 MG Oral Tablet	PSN	92ae2611-637c-4a9e-8e95-2d8fa8191f03	3
197517	clarithromycin 500 MG Oral Tablet	SCD	92ae2611-637c-4a9e-8e95-2d8fa8191f03	3
197517	clarithromycin 500 MG Oral Tablet	PSN	146e570b-c0d0-4879-9f58-8cf6287af9a6	2
197517	clarithromycin 500 MG Oral Tablet	SCD	146e570b-c0d0-4879-9f58-8cf6287af9a6	2
197516	clarithromycin 250 MG Oral Tablet	PSN	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	PSN	28f60574-4ecd-441c-aebe-5b1d18033ef6	1
197517	clarithromycin 500 MG Oral Tablet	PSN	c14051fd-deeb-4340-b9a9-9482ef6c198c	1
197517	clarithromycin 500 MG Oral Tablet	PSN	a12e4d38-e0f8-4467-a26c-bb25a342aa92	1
197517	clarithromycin 500 MG Oral Tablet	PSN	ece57ade-11e0-7057-e053-2a95a90a26d7	1
197517	clarithromycin 500 MG Oral Tablet	PSN	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	PSN	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	1
197516	clarithromycin 250 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	SCD	28f60574-4ecd-441c-aebe-5b1d18033ef6	1
197517	clarithromycin 500 MG Oral Tablet	SCD	c14051fd-deeb-4340-b9a9-9482ef6c198c	1
197517	clarithromycin 500 MG Oral Tablet	SCD	a12e4d38-e0f8-4467-a26c-bb25a342aa92	1
197517	clarithromycin 500 MG Oral Tablet	SCD	ece57ade-11e0-7057-e053-2a95a90a26d7	1
197517	clarithromycin 500 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	SCD	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1962-01	00781196201	100 in 1 BOTTLE						Historical
0781-1962-05	00781196205	500 in 1 BOTTLE						Historical
0781-1962-31	00781196231	30 in 1 BOTTLE						Historical
0781-1962-60	00781196260	60 TABLET in 1 BOTTLE (0781-1962-60)	60 tablet	2005-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Clarithromycin	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	29
Clarithromycin	Coupler LLC	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin	DirectRx	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
Clarithromycin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-06-27	HUMAN PRESCRIPTION DRUG LABEL	7
Clarithromycin	Bryant Ranch Prepack	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	6
Clarithromycin	Proficient Rx LP	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin	A-S Medication Solutions	2023-12-14	HUMAN PRESCRIPTION DRUG LABEL	8
Clarithromycin	Sandoz Inc	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	23
Clarithromycin	NuCare Pharmaceuticals,Inc.	2022-11-07	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin	RPK Pharmaceuticals, Inc.	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	2
Clarithromycin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-10-20	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin - Life Line Home Care Services, Inc.	Life Line Home Care Services, Inc.	2012-02-07	HUMAN PRESCRIPTION DRUG LABEL	1
Clarithromycin Tablets, USP	Physicians Total Care, Inc.	2012-02-01	HUMAN PRESCRIPTION DRUG LABEL	3
Clarithromycin Tablets, USP	Rebel Distributors Corp.	2010-09-15	HUMAN PRESCRIPTION DRUG LABEL	1

Clarithromycin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

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#