FDA.reportPublic FDA data

Azithromycin

Product NDC
54348-857
11-digit product format
543480857
Labeler code
54348
Product ID
54348-857_eb018961-75d1-2d69-e053-2995a90a38be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA065225
Marketing category
ANDA
Marketing start
2019-07-10
Substance
AZITHROMYCIN MONOHYDRATE
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 MONOHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
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
54348-857-00Azithromycin1 in 1 BOXTABLET, FILM COATED12
54348-857-00Azithromycin1 in 1 BOTTLETABLET, FILM COATED12
54348-857-01Azithromycin1 in 1 BOTTLETABLET, FILM COATED12
54348-857-01Azithromycin1 in 1 BOXTABLET, FILM COATED12
54348-857-02Azithromycin1 in 1 BOXTABLET, FILM COATED12
54348-857-02Azithromycin2 in 1 BOTTLETABLET, FILM COATED22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54348-857-02EA - Each54348-857adbedb77-b9e0-4fa4-91da-0fd3292d3bc712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-857AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [PHARMPAK, INC.]2Current NDC, Legacy NDC, 6 package rows20221015_ba57ff26-cd02-4f57-ac92-b613d245a4ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNba57ff26-cd02-4f57-ac92-b613d245a4ea2
248656azithromycin 500 MG Oral TabletSCDba57ff26-cd02-4f57-ac92-b613d245a4ea2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYba57ff26-cd02-4f57-ac92-b613d245a4ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-857-00543480857001 BOTTLE in 1 BOX (54348-857-00) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-857-01543480857011 BOTTLE in 1 BOX (54348-857-01) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent
54348-857-02543480857021 BOTTLE in 1 BOX (54348-857-02) / 2 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-100000-00-00NoNoCurrent