NDC 64679-964-03 - Azithromycin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 64679-964
Requested NDC: 64679-964-03
Package NDCs from labels: 64679-964-01, 64679-964-07, 64679-964-03, 64679-964-05, 64679-964-09, 64679-964-02, 64679-964-08
Manufacturer: Bryant Ranch Prepack
Effective date: 2022-02-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Azithromycin - Bryant Ranch Prepack	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Wockhardt USA LLC. \| Vivimed Life Sciences Private Limited	Wockhardt USA LLC. \| Vivimed Life Sciences Private Limited	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Proficient Rx LP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2020-12-24	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - AvPAK	AvPAK	2020-04-24	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2018-12-26	HUMAN PRESCRIPTION DRUG LABEL
ZITHROMAX - DIRECT RX	DIRECT RX	2016-05-27	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Dispensing Solutions, Inc.	Dispensing Solutions, Inc.	2011-09-06	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - STAT RX USA LLC	STAT RX USA LLC	2011-01-27	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Rebel Distributors Corp.	Rebel Distributors Corp.	2010-02-01	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit
AZITHROMYCIN - Dispensing Solutions Inc.	Dispensing Solutions Inc.	2010-02-18	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-964-01	2024-11-14	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-02	2024-11-14	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-05	2024-11-14	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-07	2024-11-14	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-08	2024-11-14	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-01	2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-02	2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-05	2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-07	2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
64679-964-08	2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-964-01	EA - Each	64679-964	3d29e384-297e-4c81-be79-723f46323f62	1	2012-07-24
64679-964-02	EA - Each	64679-964	2e420ffd-6ae9-4527-91c2-44b336f5a25d	1	2022-04-06
64679-964-03	EA - Each	64679-964	c823e48a-73ff-4315-8ca1-8427740b7d6b	1	2012-07-24
64679-964-05	EA - Each	64679-964	ac94c3db-9f4c-4aa5-b32a-d35d31644eb7	1	2012-07-24
64679-964-07	EA - Each	64679-964	fbcf7ed8-5822-4476-beb0-90fe8fbb4c38	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Azithromycin Anhydrous	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Azithromycin Anhydrous	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Hydroxypropyl Cellulose (type H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Magnesium Trisilicate	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]	1

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 9 of 145 · 2,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eryfotona Actinica Tinted	TITANIUM DIOXIDE	ISDIN Corp.	97357703-0e93-4216-bd1b-a9b202781959	2026-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Vermex	ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM	BioActive Nutritional, Inc.	6be5fbcf-bb22-4b20-b65a-d943c516adf9	2026-06-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mineral Mattescreen SPF 40 - Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	08671d39-3be2-d666-e063-6294a90a6207	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden Hour	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	c2398820-f003-707f-e053-2a95a90a6929	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Episciences, Inc.	3d1e2921-cba9-4446-e054-00144ff8d46c	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
VitaPhyte Redness Reliever Lubricant Eye Drops	REDNESS RELIEVER LUBRICANT EYE DROPS	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53d4e9b0-c9a0-797a-e063-6294a90ad0cf	2026-06-04	Warnings	Exact identifier unii: B697894SGQ
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GB	ZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5354af18-50c4-5fba-e063-6394a90ace39	2026-06-03	Warnings	Exact identifier unii: 15FIX9V2JP
BM Silicea Icing Sugar	SILICEA ICING SUGAR	Total Operations Management LLC DBA:Bestmade Natural Products Micro	535ba100-627f-36b4-e063-6394a90a3373	2026-06-03	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto Digi-Eye	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE	The Mentholatum Company	5d6f37b9-b568-4cb6-92de-eb40779f3f8c	2026-06-03	Warnings	Exact identifier unii: 3NXW29V3WO
ATOMY BB SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b0cd27ee-4917-4800-bcdf-c6e14b28c1d1	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	ad0b9091-a990-45bf-93f4-d886be1bbffe	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	994d5680-284e-4faf-a29b-4d28f8d46e8f	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a8d60212-18a7-42af-8bb3-bfcff7690a49	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
The Mineral Melt SPF30	ZINC OXIDE, TITANIUM DIOXIDE	Dune Suncare Inc.	2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	a1acb789-5bf4-4447-b3c5-4a7d4d3013a7	2026-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
BM Tooth Remineralization	CALC PHOS, CALC FLUOR, SILICEA	BM Private Limited	5331dc40-2ac8-5fce-e063-6394a90a5875	2026-06-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Savings Distributors LLC	558178eb-1eec-af0f-e063-6394a90afad9	2026-06-01	Warnings	Exact identifier unii: B697894SGQ
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier unii: 15FIX9V2JP
Blink Triple Care Preservative Free	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	65e67990-78b7-4ce9-963b-6bed3a6bed07	2026-05-27	Warnings	Exact identifier unii: B697894SGQ
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	52ba9423-8b9b-38f7-e063-6394a90a95da	2026-05-26	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.