FDA.reportPublic FDA data

Azithromycin

Product NDC
0093-7148
11-digit product format
000937148
Labeler code
0093
Product ID
0093-7148_98f701e6-6825-4360-8cdb-6d91f5962a75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Monohydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065419
Marketing category
ANDA
Marketing start
2008-09-22
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7148-23ML - Milliliter0093-7148fadf6612-be8d-4472-9564-89a0921a8e4e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
azithromycin monohydrateACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
azithromycinACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
ethyl vanillinINACTIVE INGREDIENTYC9ST449YJAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
vanillinINACTIVE INGREDIENTCHI530446XAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN58b72e4c-f419-4a70-b894-93a5804d99932
308459azithromycin 20 MG/ML Oral SuspensionSCD58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 40 MG/ML Oral SuspensionSCD58b72e4c-f419-4a70-b894-93a5804d99932
308459azithromycin 100 MG per 5 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 200 MG per 5 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 600 MG per 15 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932