NDC 64679-961-04 - 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: 64679-961
Requested NDC: 64679-961-04
Package NDCs from labels: 64679-961-01, 64679-961-07, 64679-961-04, 64679-961-05, 64679-961-09, 64679-961-02, 64679-961-08
Manufacturer: Wockhardt USA LLC. | Vivimed Life Sciences Private Limited
Effective date: 2021-12-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
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 - AvPAK	AvPAK	2020-04-24	HUMAN PRESCRIPTION DRUG LABEL
ZITHROMAX - DIRECT RX	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Lake Erie Medical DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	2019-11-13	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - A-S Medication Solutions	A-S Medication Solutions	2018-04-16	HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Unit Dose Services	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - RxChange Co.	RxChange Co.	2014-11-19	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Aidarex Pharmaceuticals LLC	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Dispensing Solutions, Inc.	Dispensing Solutions, Inc.	2011-09-06	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-961-01	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
64679-961-02	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
64679-961-05	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
64679-961-07	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
64679-961-08	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
64679-961-01	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
64679-961-02	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
64679-961-05	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
64679-961-07	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
64679-961-08	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
64679-961-01	EA - Each	64679-961	644a2175-b839-428f-8572-d3c75e30d235	1	2012-07-24
64679-961-02	EA - Each	64679-961	d5e1d78d-7318-4405-9102-e13380aa2a3c	1	2022-04-06
64679-961-04	EA - Each	64679-961	b71506f1-f812-4bc6-b634-85425fc2028d	1	2012-07-24
64679-961-05	EA - Each	64679-961	d87c8206-1f44-470e-92a8-685622ffd913	1	2012-07-24
64679-961-07	EA - Each	64679-961	f0dc0378-b555-46df-bfab-188c80a5e7d2	1	2012-07-24
64679-961-08	EA - Each	64679-961	e93d0680-275d-4470-aa16-f2f7070b30c2	1	2022-04-06

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 [UNIT DOSE SERVICES]	2
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]	2
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 [AIDAREX PHARMACEUTICALS LLC]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS 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 1 of 146 · 2,906 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2026-09-09	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2026-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 308460 unii: 5FD1131I7S
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier unii: B697894SGQ
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	3c902990-b870-4725-b9fe-76b8be633e1c	2026-09-03	Warnings, Adverse reactions	Exact identifier unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 308460 rxcui: 248656 unii: 5FD1131I7S
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 248656 unii: 5FD1131I7S
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-09-02	Warnings, Adverse reactions	Exact identifier rxcui: 749780 rxcui: 308460 rxcui: 248656 rxcui: 749783 unii: 5FD1131I7S
BMNP Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a58454f-aed6-24ba-e063-6294a90a47fb	2026-08-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	0d5129e4-8b94-4a4d-baa9-be0d6b32d714	2026-08-31	Warnings, Adverse reactions	Exact identifier unii: 5FD1131I7S
Azithromycin Dihydrate	AZITHROMYCIN DIHYDRATE	REMEDYREPACK INC.	f0cfda1a-910f-4764-8658-263037df5ea8	2026-08-28	Warnings, Adverse reactions	Exact identifier rxcui: 308460 rxcui: 749783 unii: 5FD1131I7S
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Endometrium Argentum	ENDOMETRIUM ARGENTUM	Uriel Pharmacy Inc	d2d1428a-c8b5-9529-e053-2995a90a2343	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
S12 AIRBORNE	ALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEAT	Apex Energetics Inc.	bb0036c3-1e4d-5750-e053-2995a90ae895	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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