FDA.reportPublic FDA data

azithromycin

Product NDC
70518-4367
11-digit product format
705184367
Labeler code
70518
Product ID
70518-4367_3ff1f6a7-77d5-1da0-e063-6294a90a2099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065399
Marketing category
ANDA
Marketing start
2025-06-20
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
azithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4367-0azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED303
70518-4367-1azithromycin2 in 1 BOXTABLET, FILM COATED23
70518-4367-2azithromycin1 in 1 POUCHTABLET, FILM COATED13
70518-4367-3azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNbf061799-cdef-40f8-b1ce-bc5eb609f8c33
248656azithromycin 500 MG Oral TabletSCDbf061799-cdef-40f8-b1ce-bc5eb609f8c33
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbf061799-cdef-40f8-b1ce-bc5eb609f8c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4367-07051843670030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4367-0) 2025-06-20NoNoCurrent
70518-4367-1705184367012 POUCH in 1 BOX (70518-4367-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4367-2) 2 pouch2025-06-25NoNoCurrent
70518-4367-2705184367021 in 1 POUCHHistorical
70518-4367-3705184367032 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-3) 2025-09-26NoNoCurrent