Azithromycin

Product NDC
68071-4785
11-digit product format
680714785
Labeler code
68071
Product ID
68071-4785_bb8e0588-7f66-5e3b-e053-2a95a90a47e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211147
Marketing category
ANDA
Marketing start
2018-08-06
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4785-5Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4785AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 1 package rows20210219_82d418ad-9ad6-18f8-e053-2a91aa0af084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN82d418ad-9ad6-18f8-e053-2a91aa0af0843
141963azithromycin 40 MG/ML Oral SuspensionSCD82d418ad-9ad6-18f8-e053-2a91aa0af0843
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY82d418ad-9ad6-18f8-e053-2a91aa0af0843
141963azithromycin 200 MG per 5 ML Oral SuspensionSY82d418ad-9ad6-18f8-e053-2a91aa0af0843
141963azithromycin 600 MG per 15 ML Oral SuspensionSY82d418ad-9ad6-18f8-e053-2a91aa0af0843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4785-56807147850515 mL in 1 BOTTLE (68071-4785-5) 15 ml2019-02-260000-00-00NoNoCurrent