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 5 of 145 · 2,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Exact identifier rxcui: 749780 rxcui: 248656 unii: 5FD1131I7S
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Exact identifier rxcui: 308460 unii: 5FD1131I7S
Prid	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	49689eeb-7790-07f1-e063-6294a90a2df2	2026-07-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 308460 unii: 5FD1131I7S
Leg Cramps PM	OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR	Hyland's Inc.	b0574a7e-88fa-417e-b6d5-60ced59eba47	2026-07-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12	SILICEA	Zettl Health Inc.	5647dafc-1fff-6a25-e063-6294a90a8b4f	2026-07-10		Exact identifier unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP
Artificial Tears	ARTIFICIAL TEARS	AvPAK	f18bebf2-1936-658f-e053-2a95a90a5012	2026-07-07	Warnings	Exact identifier unii: 3NXW29V3WO
EELHOE Body Coverage Perfector	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5610c3b7-456b-3bc1-e063-6394a90a3fa8	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Emerald Aesthetics LLC	55f88dd1-346c-22a5-e063-6294a90a711f	2026-07-06	Warnings	Exact identifier unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	LG H&H Co., Ltd.	d307471c-6cc6-ce48-e053-2995a90a3e02	2026-07-02	Warnings	Exact identifier unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Eden Brands Inc.	2cb7773f-9a05-ad02-e063-6294a90af024	2026-07-01	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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