FDA.reportPublic FDA data

Azithromycin

Product NDC
0093-7149
11-digit product format
000937149
Labeler code
0093
Product ID
0093-7149_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
200 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 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7149-23ML - Milliliter0093-7149e542efdd-c691-482c-8fbd-d6a261847dc612012-07-24
0093-7149-31ML - Milliliter0093-7149132d28f9-b829-42c6-a682-fbc57543fd4a12012-07-24
0093-7149-94ML - Milliliter0093-7149a737d829-9001-4f8b-ba56-1cc1eca7741112012-07-24

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
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
VANILLININACTIVE INGREDIENTCHI530446XAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.]1

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
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 40 MG/ML Oral SuspensionSCD4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 200 MG per 5 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1
141963azithromycin 600 MG per 15 ML Oral SuspensionSY4e9ac94f-4d85-4731-8b7f-6188209b4a9c1