FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
42806-150
11-digit product format
428060150
Labeler code
42806
Product ID
42806-150_8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA207531
Marketing category
ANDA
Marketing start
2018-04-10
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZITHROMYCIN
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-150-33AZITHROMYCIN22.5 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION22.516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-150-33ML - Milliliter42806-150670b4969-04a9-480e-a932-c470cbabd0fb12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-150AZITHROMYCIN POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]14Current NDC, Legacy NDC, 1 package rows20221230_59c4b783-4ff7-4269-969b-58a10e12b12b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN59c4b783-4ff7-4269-969b-58a10e12b12b16
308459azithromycin 20 MG/ML Oral SuspensionSCD59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 40 MG/ML Oral SuspensionSCD59c4b783-4ff7-4269-969b-58a10e12b12b16
308459azithromycin 100 MG per 5 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 200 MG per 5 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 600 MG per 15 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN76093152-e2d7-4fe1-8568-1f0fec1747c25
141963azithromycin 40 MG/ML Oral SuspensionSCD76093152-e2d7-4fe1-8568-1f0fec1747c25
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY76093152-e2d7-4fe1-8568-1f0fec1747c25
141963azithromycin 200 MG per 5 ML Oral SuspensionSY76093152-e2d7-4fe1-8568-1f0fec1747c25
141963azithromycin 600 MG per 15 ML Oral SuspensionSY76093152-e2d7-4fe1-8568-1f0fec1747c25
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNd564d91e-3039-c120-e053-2995a90ae6db2
141963azithromycin 40 MG/ML Oral SuspensionSCDd564d91e-3039-c120-e053-2995a90ae6db2
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYd564d91e-3039-c120-e053-2995a90ae6db2
141963azithromycin 200 MG per 5 ML Oral SuspensionSYd564d91e-3039-c120-e053-2995a90ae6db2
141963azithromycin 600 MG per 15 ML Oral SuspensionSYd564d91e-3039-c120-e053-2995a90ae6db2
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN3f7c7421-411d-c04e-e063-6394a90a4aa01
141963azithromycin 40 MG/ML Oral SuspensionSCD3f7c7421-411d-c04e-e063-6394a90a4aa01
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY3f7c7421-411d-c04e-e063-6394a90a4aa01
141963azithromycin 200 MG per 5 ML Oral SuspensionSY3f7c7421-411d-c04e-e063-6394a90a4aa01
141963azithromycin 600 MG per 15 ML Oral SuspensionSY3f7c7421-411d-c04e-e063-6394a90a4aa01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-150-334280601503322.5 mL in 1 BOTTLE, PLASTIC (42806-150-33) 22.5 ml2018-04-100000-00-00NoNoCurrent