FDA.reportPublic FDA data

Azithromycin

Product NDC
25021-180
11-digit product format
250210180
Labeler code
25021
Product ID
25021-180_220cc340-9433-448e-8f66-929912777900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA065501
Marketing category
ANDA
Marketing start
2025-08-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-180-10Azithromycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
25021-180-10Azithromycin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,51
25021-180-66Azithromycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101
25021-180-66Azithromycin5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-180AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20240925_6497fb5e-82d8-4411-b994-7ee01333ffd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668238azithromycin 500 MG InjectionPSN6497fb5e-82d8-4411-b994-7ee01333ffd71
1668238azithromycin 500 MG InjectionPSNcefbce3f-3e6c-4659-abd7-3ec3e82277371
1668238azithromycin 500 MG InjectionSCD6497fb5e-82d8-4411-b994-7ee01333ffd71
1668238azithromycin 500 MG InjectionSCDcefbce3f-3e6c-4659-abd7-3ec3e82277371
1668238azithromycin (as azithromycin dihydrate) 500 MG InjectionSY6497fb5e-82d8-4411-b994-7ee01333ffd71
1668238azithromycin (as azithromycin dihydrate) 500 MG InjectionSYcefbce3f-3e6c-4659-abd7-3ec3e82277371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-180-102502101801010 VIAL in 1 CARTON (25021-180-10) / 5 mL in 1 VIAL10 vial2025-08-01NoNoCurrent
25021-180-662502101806610 VIAL in 1 CARTON (25021-180-66) / 5 mL in 1 VIAL10 vial2024-09-15NoNoCurrent