FDA.reportPublic FDA data

Azithromycin monohydrate

Product NDC
70095-025
11-digit product format
700950025
Labeler code
70095
Product ID
70095-025_dd9fbcb9-f8e5-417f-98b0-6ba9939982c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin monohydrate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries Limited
Application
ANDA065501
Marketing category
ANDA
Marketing start
2023-03-27
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/10mL
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 monohydrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/10mL

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
70095-025-01Azithromycin monohydrate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,102
70095-025-02Azithromycin monohydrate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70095-025-01EA - Each70095-025a5df2849-d058-4724-a692-2dfc97ab388f12023-07-06
70095-025-02EA - Each70095-0254c743520-0901-442c-9ca4-bd14d2b6457712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70095-025AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED]2Current NDC, 2 package rows20230621_c8d012c4-f411-4484-a618-7597599ea621.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668238azithromycin 500 MG InjectionPSNc8d012c4-f411-4484-a618-7597599ea6212
1668238azithromycin 500 MG InjectionSCDc8d012c4-f411-4484-a618-7597599ea6212
1668238azithromycin (as azithromycin dihydrate) 500 MG InjectionSYc8d012c4-f411-4484-a618-7597599ea6212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-025-017009500250110 mL in 1 VIAL10 mlHistorical
70095-025-027009500250210 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01) 10 vial2023-03-27NoNoCurrent