azithromycin

Product NDC
59762-3051
11-digit product format
597623051
Labeler code
59762
Product ID
59762-3051_b524bc31-a46c-41f5-a2d5-40166d1ec6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050693
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1999-02-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1 g/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59762-3051-12024-01-30C16284748780-11030e365-1af3-111a-e063-dadaa90a10e2d470695c-c0d7-4361-8783-45f58a932ac4
59762-3051-22024-01-30C16284748780-11030e365-1af3-111a-e063-dadaa90a10e2d470695c-c0d7-4361-8783-45f58a932ac4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3051-1EA - Each59762-305132906e18-60c6-4dbb-ab1e-b44cb6e29a1312012-07-24
59762-3051-2EA - Each59762-3051399898d4-5993-442f-95e5-937401b3dedc12012-07-24
59762-3051-5EA - Each59762-30511cf6569f-c8e7-4e9b-a53f-0097c4585ae312021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
azithromycinACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
azithromycinACTIVE MOIETYF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-3051AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]36Legacy NDC20250206_d470695c-c0d7-4361-8783-45f58a932ac4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861416azithromycin 1 GM Powder for Oral SuspensionPSN0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSCD0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1 GM Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1 GM Powder for Oral SuspensionPSN53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1 GM Powder for Oral SuspensionPSN5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1000 MG Powder for Oral SuspensionSCD53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSCD5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1 GM Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1 GM Powder for Oral SuspensionSY5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1000 MG Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSY5a96f4e1-6b80-42a2-8d85-95a1ff8920992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-3051-15976230510110 PACKET in 1 BOX (59762-3051-1) > 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5) 10 packet1999-02-120000-00-00NoNoCurrent
59762-3051-2597623051023 PACKET in 1 BOX (59762-3051-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5) 3 packet1999-02-120000-00-00NoNoCurrent