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
LabelManufacturerEffective dateType
Azithromycin - Bryant Ranch PrepackBryant Ranch Prepack2022-02-09HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Wockhardt USA LLC. | Vivimed Life Sciences Private LimitedWockhardt USA LLC. | Vivimed Life Sciences Private Limited2021-12-08HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-16HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Proficient Rx LPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2020-12-24HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2020-12-23HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - AvPAKAvPAK2020-04-24HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2018-12-26HUMAN PRESCRIPTION DRUG LABEL
ZITHROMAX - DIRECT RXDIRECT RX2016-05-27HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2013-12-12HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Dispensing Solutions, Inc.Dispensing Solutions, Inc.2011-09-06HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - STAT RX USA LLCSTAT RX USA LLC2011-01-27HUMAN PRESCRIPTION DRUG LABEL
AZITHROMYCIN - Rebel Distributors Corp.Rebel Distributors Corp.2010-02-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit
AZITHROMYCIN - Dispensing Solutions Inc.Dispensing Solutions Inc.2010-02-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-964-012024-11-14These 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
64679-964-022024-11-14These 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
64679-964-052024-11-14These 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
64679-964-072024-11-14These 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
64679-964-082024-11-14These 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
64679-964-012023-01-30These 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
64679-964-022023-01-30These 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
64679-964-052023-01-30These 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
64679-964-072023-01-30These 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
64679-964-082023-01-30These 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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-964-01EA - Each64679-9643d29e384-297e-4c81-be79-723f46323f6212012-07-24
64679-964-02EA - Each64679-9642e420ffd-6ae9-4527-91c2-44b336f5a25d12022-04-06
64679-964-03EA - Each64679-964c823e48a-73ff-4315-8ca1-8427740b7d6b12012-07-24
64679-964-05EA - Each64679-964ac94c3db-9f4c-4aa5-b32a-d35d31644eb712012-07-24
64679-964-07EA - Each64679-964fbcf7ed8-5822-4476-beb0-90fe8fbb4c3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Azithromycin AnhydrousACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Azithromycin AnhydrousACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Magnesium StearateINACTIVE INGREDIENT70097M6I30AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Magnesium TrisilicateINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Starch, CornINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]15
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]4
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN 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 6 of 145 · 2,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 308460
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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