FDA.reportPublic FDA data

Azithromycin

Product NDC
70518-0784
11-digit product format
705180784
Labeler code
70518
Product ID
70518-0784_48372a1c-5fe3-bf47-e063-6394a90a43c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2017-10-12
Substance
AZITHROMYCIN MONOHYDRATE
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui308460

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
70518-0784-0Azithromycin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED617
70518-0784-1Azithromycin4 in 1 BOTTLE, PLASTICTABLET, FILM COATED417
70518-0784-2Azithromycin30 in 1 BOXTABLET, FILM COATED3017
70518-0784-3Azithromycin1 in 1 POUCHTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0784-1EA - Each70518-0784b635d4c4-6f88-45e1-b0c1-f64f8539e71e12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0784AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 4 package rows20250429_333ffe63-aaeb-4dff-b595-1c11209189a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN333ffe63-aaeb-4dff-b595-1c11209189a617
308460azithromycin 250 MG Oral TabletSCD333ffe63-aaeb-4dff-b595-1c11209189a617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0784-0705180784006 in 1 BOTTLE, PLASTICHistorical
70518-0784-1705180784014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0784-1) 2019-12-230000-00-00NoNoCurrent
70518-0784-27051807840230 in 1 BOXHistorical
70518-0784-3705180784031 in 1 POUCHHistorical