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 8 of 145 · 2,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scar Control	CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE	Forces of Nature	595c3423-6b52-48fc-8a95-00b53c1ecc7b	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54243745-bd67-19c1-e063-6394a90a4b72	2026-06-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	BM Private Limited	540d8fbe-3bdb-1b54-e063-6394a90a114d	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM5 DROPS	APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC	Total Operations Management LLC DBA:Bestmade Natural Products Micro	540e4ee3-596f-4cea-e063-6294a90a6a60	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	7711e846-0bb3-486c-8511-f445e264cd98	2026-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
Visine Red Eye Total Comfort Multi-Symptom	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	5747edef-7a87-41d7-9594-6c78508b9ba2	2026-06-11	Warnings	Exact identifier unii: B697894SGQ
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen	ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE	IT COSMETICS, LLC	f2990320-b61d-40b8-ba79-18d6b37e7f52	2026-06-11	Warnings	Exact identifier unii: 15FIX9V2JP
Jacksons Cell Salts SKIN BALANCE	CALC SULPH, KALI SULPH, SILICEA	Zettl Health Inc.	54012f03-4c34-42f5-e063-6394a90aacc5	2026-06-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM5 DROPS	APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC	BM Private Limited	53e763ee-9a44-a914-e063-6394a90aeb3c	2026-06-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
GUNA-AWARENESS	BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -	Guna spa	10e46b39-7903-4390-b72d-865291245b4c	2026-06-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BIO28 ALCOHOL	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	53d1c51a-77eb-bb3c-e063-6394a90aab3f	2026-06-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BIO18	CALC FLUOR, CALC SULF, SILICEA.	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53d3c1d6-d0ba-5ea7-e063-6394a90a0294	2026-06-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d76b02-442e-7a5d-e063-6394a90ae1b3	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d9d689-4a86-5b9c-e063-6394a90aef18	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
BM Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53bb3927-6053-eb3d-e063-6394a90a5ddf	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scrofularoforce	RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA	BioActive Nutritional, Inc.	737cd410-0405-41b0-b7f2-29bb20037849	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen	TITANIUM DIOXIDE	ISDIN Corp.	293a1116-e8a2-495f-83db-20dd82ed13c2	2026-06-08	Warnings	Exact identifier unii: 15FIX9V2JP
VAX	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,	BioActive Nutritional, Inc.	faa4a678-321a-4982-a5d4-01b713e6862d	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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