FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
70518-3168
11-digit product format
705183168
Labeler code
70518
Product ID
70518-3168_4ecb001a-755e-6e29-e063-6394a90a10a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2022-01-19
Marketing end
2026-10-31
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3168-0Azithromycin Dihydrate2 in 1 BOXTABLET, FILM COATED210
70518-3168-1Azithromycin Dihydrate2 in 1 BOTTLE, PLASTICTABLET, FILM COATED210
70518-3168-2Azithromycin Dihydrate1 in 1 POUCHTABLET, FILM COATED110
70518-3168-3Azithromycin Dihydrate30 in 1 BLISTER PACKTABLET, FILM COATED3010
70518-3168-4Azithromycin Dihydrate3 in 1 BOTTLE, PLASTICTABLET, FILM COATED310
70518-3168-5Azithromycin Dihydrate5 in 1 BOTTLE, PLASTICTABLET, FILM COATED510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3168AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 6 package rows20240927_c7ed6985-1d1d-48af-9df8-64b12821789e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNc7ed6985-1d1d-48af-9df8-64b12821789e10
248656azithromycin 500 MG Oral TabletSCDc7ed6985-1d1d-48af-9df8-64b12821789e10
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYc7ed6985-1d1d-48af-9df8-64b12821789e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3168-0705183168002 TABLET, FILM COATED in 1 BLISTER PACK (70518-3168-0) 2021-07-220000-00-00NoNoCurrent
70518-3168-1705183168012 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3168-1) 2022-01-192026-10-31NoNoCurrent
70518-3168-2705183168021 in 1 POUCHHistorical
70518-3168-37051831680330 TABLET, FILM COATED in 1 BLISTER PACK (70518-3168-3) 2022-11-280000-00-00NoNoCurrent
70518-3168-4705183168043 in 1 BOTTLE, PLASTICHistorical
70518-3168-5705183168055 in 1 BOTTLE, PLASTICHistorical