FDA.reportPublic FDA data

Azithromycin

Product NDC
70710-1459
11-digit product format
707101459
Labeler code
70710
Product ID
70710-1459_6cf603d4-b79b-4a0a-906c-f1967a0db9a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211147
Marketing category
ANDA
Marketing start
2018-08-06
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 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 DIHYDRATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui141963, 308459

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
70710-1459-2Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.57
70710-1459-2Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1459-2ML - Milliliter70710-1459bd52b648-aa3d-4420-81bb-5e5d0232ac2f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1459AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250110_99e5bd22-a721-4e2e-a46c-d61a53c25c3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
308459azithromycin 20 MG/ML Oral SuspensionSCD99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 40 MG/ML Oral SuspensionSCD99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
308459azithromycin 100 MG per 5 ML Oral SuspensionSY99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 200 MG per 5 ML Oral SuspensionSY99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 600 MG per 15 ML Oral SuspensionSY99e5bd22-a721-4e2e-a46c-d61a53c25c3d7
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNf4d69065-b3a3-091b-e053-2995a90ac6741
141963azithromycin 40 MG/ML Oral SuspensionSCDf4d69065-b3a3-091b-e053-2995a90ac6741
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYf4d69065-b3a3-091b-e053-2995a90ac6741
141963azithromycin 200 MG per 5 ML Oral SuspensionSYf4d69065-b3a3-091b-e053-2995a90ac6741
141963azithromycin 600 MG per 15 ML Oral SuspensionSYf4d69065-b3a3-091b-e053-2995a90ac6741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1459-2707101459021 BOTTLE in 1 CARTON (70710-1459-2) / 22.5 mL in 1 BOTTLE1 bottle2018-08-060000-00-00NoNoCurrent