FDA.reportPublic FDA data

Azithromycin

Product NDC
62756-512
11-digit product format
627560512
Labeler code
62756
Product ID
62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090923
Marketing category
ANDA
Marketing start
2020-07-15
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui1668238

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62756-512-442020-06-16C16284748780-19d75b9d0-9103-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991
62756-512-442020-01-31C16284748780-19d75b9d0-9103-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-512-40Azithromycin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,519
62756-512-44Azithromycin10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-512AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20200715_6a22beb6-57e8-480d-97b5-44d9dbfabf93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668238azithromycin 500 MG InjectionPSN6a22beb6-57e8-480d-97b5-44d9dbfabf9319
1668238azithromycin 500 MG InjectionSCD6a22beb6-57e8-480d-97b5-44d9dbfabf9319
1668238azithromycin (as azithromycin dihydrate) 500 MG InjectionSY6a22beb6-57e8-480d-97b5-44d9dbfabf9319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-512-40627560512405 mL in 1 VIAL5 mlHistorical
62756-512-446275605124410 VIAL in 1 PACKAGE (62756-512-44) / 5 mL in 1 VIAL (62756-512-40) 10 vial2020-07-150000-00-00NoNoCurrent