FDA.reportPublic FDA data

Azithromycin

Product NDC
70518-3254
11-digit product format
705183254
Labeler code
70518
Product ID
70518-3254_51a122a0-b474-d0c8-e063-6394a90adf23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211792
Marketing category
ANDA
Marketing start
2021-10-23
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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 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
70518-3254-0Azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-3254-1Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED214
70518-3254-2Azithromycin2 in 1 BOXTABLET, FILM COATED214
70518-3254-3Azithromycin1 in 1 POUCHTABLET, FILM COATED114
70518-3254-4Azithromycin3 in 1 BOTTLE, PLASTICTABLET, FILM COATED314
70518-3254-5Azithromycin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3254-0EA - Each70518-3254d9d410e6-1168-4c36-919c-6b74e50d80b812026-02-05
70518-3254-1EA - Each70518-3254c8cbf5ef-506a-4845-b4d1-1092810414a212026-02-05
70518-3254-2EA - Each70518-3254f6512e24-2368-44d0-8e1c-afa74882300012026-02-05
70518-3254-3EA - Each70518-3254dd475b86-7b02-4f39-86ad-5af9522d1c6d12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3254AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 6 package rows20250315_614cc2a4-3fc7-455d-9e8a-212c496f0fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN614cc2a4-3fc7-455d-9e8a-212c496f0fbf14
248656azithromycin 500 MG Oral TabletSCD614cc2a4-3fc7-455d-9e8a-212c496f0fbf14
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY614cc2a4-3fc7-455d-9e8a-212c496f0fbf14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3254-07051832540030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3254-0) 2021-10-230000-00-00NoNoCurrent
70518-3254-1705183254012 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3254-1) 2022-01-140000-00-00NoNoCurrent
70518-3254-2705183254022 POUCH in 1 BOX (70518-3254-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3254-3) 2 pouch2022-02-100000-00-00NoNoCurrent
70518-3254-3705183254031 in 1 POUCHHistorical
70518-3254-4705183254043 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3254-4) 2022-05-10NoNoCurrent
70518-3254-5705183254055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3254-5) 2026-05-12NoNoCurrent