FDA.reportPublic FDA data

Azithromycin

Product NDC
70860-125
11-digit product format
708600125
Labeler code
70860
Product ID
70860-125_2cc927cf-6a15-6851-e063-6394a90a0b8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin monohydrate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA065501
Marketing category
ANDA
Marketing start
2019-08-30
Marketing end
2027-03-31
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin

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
70860-125-662024-03-02C16284748780-11030e365-632f-111a-e063-dadaa90a10e2These 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
70860-125-662024-01-30C16284748780-11030e365-632f-111a-e063-dadaa90a10e2These 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
70860-125-41Azithromycin5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,56
70860-125-66Azithromycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-125-41EA - Each70860-12526720a55-d1b0-4447-aa1b-1e4d80a369c812020-01-03
70860-125-66EA - Each70860-1256badb9b6-f5f5-46e1-8e33-dab75b4f267c12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-125AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]6Current NDC, Legacy NDC, 2 package rows20250130_610a34ea-6aa7-4b94-a85a-ff16ca537d03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668238azithromycin 500 MG InjectionPSN610a34ea-6aa7-4b94-a85a-ff16ca537d036
1668238azithromycin 500 MG InjectionSCD610a34ea-6aa7-4b94-a85a-ff16ca537d036
1668238azithromycin (as azithromycin dihydrate) 500 MG InjectionSY610a34ea-6aa7-4b94-a85a-ff16ca537d036

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-125-41708600125415 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
70860-125-667086001256610 VIAL, SINGLE-DOSE in 1 CARTON (70860-125-66) / 5 mL in 1 VIAL, SINGLE-DOSE (70860-125-41) 2019-08-302027-03-31NoNoCurrent