FDA.reportPublic FDA data

Azithromycin

Product NDC
68071-1527
11-digit product format
680711527
Labeler code
68071
Product ID
68071-1527_1d79fd41-f696-3620-e063-6394a90a7bbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-28
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
100 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 MONOHYDRATE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui308459

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
68071-1527-52023-07-14C16284748780-19d75b9d0-e3a7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991
68071-1527-52023-01-30C16284748780-19d75b9d0-e3a7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991
68071-1527-52021-02-11C16284748780-19d75b9d0-e3a7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991
68071-1527-52020-01-31C16284748780-19d75b9d0-e3a7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1527-5Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1527AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240719_549cdd0a-da79-23b8-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN549cdd0a-da79-23b8-e054-00144ff8d46c5
308459azithromycin 20 MG/ML Oral SuspensionSCD549cdd0a-da79-23b8-e054-00144ff8d46c5
308459azithromycin 100 MG per 5 ML Oral SuspensionSY549cdd0a-da79-23b8-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1527-56807115270515 mL in 1 BOTTLE (68071-1527-5) 15 ml2017-07-180000-00-00NoNoCurrent