FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
70518-4160
11-digit product format
705184160
Labeler code
70518
Product ID
70518-4160_49d7bf04-15e5-a936-e063-6394a90a12b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2024-08-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 749783

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
70518-4160-0Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED66
70518-4160-1Azithromycin Dihydrate30 in 1 BLISTER PACKTABLET, FILM COATED306
70518-4160-2Azithromycin Dihydrate6 in 1 BOTTLE, PLASTICTABLET, FILM COATED66
70518-4160-3Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED16
70518-4160-3Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED66
70518-4160-4Azithromycin Dihydrate2 in 1 BOTTLE, PLASTICTABLET, FILM COATED26
70518-4160-5Azithromycin Dihydrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4160AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 7 package rows20241030_f0cfda1a-910f-4764-8658-263037df5ea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf0cfda1a-910f-4764-8658-263037df5ea86
308460azithromycin 250 MG Oral TabletPSNf0cfda1a-910f-4764-8658-263037df5ea86
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf0cfda1a-910f-4764-8658-263037df5ea86
308460azithromycin 250 MG Oral TabletSCDf0cfda1a-910f-4764-8658-263037df5ea86
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf0cfda1a-910f-4764-8658-263037df5ea86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4160-0705184160006 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0) 2024-08-15NoNoCurrent
70518-4160-17051841600130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1) 2024-08-28NoNoCurrent
70518-4160-2705184160026 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2) 2024-09-23NoNoCurrent
70518-4160-3705184160031 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-04-02NoNoCurrent
70518-4160-4705184160042 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4) 2025-09-13NoNoCurrent
70518-4160-57051841600530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5) 2026-02-01NoNoCurrent