FDA.reportPublic FDA data

Azithromycin

Product NDC
55695-003
11-digit product format
556950003
Labeler code
55695
Product ID
55695-003_1287e725-48d5-e23e-e063-6394a90a96ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
Substance
AZITHROMYCIN MONOHYDRATE
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 MONOHYDRATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-003-002024-02-29C16284748780-11030e365-5674-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral use Initial U.S. Approval: 1991
55695-003-012024-02-29C16284748780-11030e365-5674-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral use Initial U.S. Approval: 1991
55695-003-002024-01-30C16284748780-11030e365-5674-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral use Initial U.S. Approval: 1991
55695-003-012024-01-30C16284748780-11030e365-5674-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use azithromycin for oral suspension USP safely and effectively. See full prescribing information for azithromycin for oral suspension USP. AZITHROMYCIN for oral suspension USP for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-003-00Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION304
55695-003-01Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-003AZITHROMYCIN POWDER, FOR SUSPENSION [STATE HEALTH SERVICES, TEXAS DEPARTMENT OF]4Current NDC, Legacy NDC, 2 package rows20240302_2b821631-0df2-0fb2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN2b821631-0df2-0fb2-e054-00144ff8d46c4
308459azithromycin 20 MG/ML Oral SuspensionSCD2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 40 MG/ML Oral SuspensionSCD2b821631-0df2-0fb2-e054-00144ff8d46c4
308459azithromycin 100 MG per 5 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 200 MG per 5 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 600 MG per 15 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55695-003-005569500030030 mL in 1 BOTTLE (55695-003-00) 30 ml2010-12-280000-00-00NoNoCurrent
55695-003-015569500030115 mL in 1 BOTTLE (55695-003-01) 15 ml2010-12-280000-00-00NoNoCurrent