FDA.reportPublic FDA data

Azithromycin

Product NDC
0093-2027
11-digit product format
000932027
Labeler code
0093
Product ID
0093-2027_cce27cc7-6d9a-496a-8989-41323c834241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, 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
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
0093-2027-23Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2027-23ML - Milliliter0093-2027f8f7fa59-3379-4f9a-94a3-c333125f883c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2027AZITHROMYCIN POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 1 package rows20220804_3209b147-11ce-4eeb-8427-5f8e6fb2c83d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSNf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
308459azithromycin 20 MG/ML Oral SuspensionSCDf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
308459azithromycin 20 MG/ML Oral SuspensionSCD3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
141963azithromycin 40 MG/ML Oral SuspensionSCDf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 40 MG/ML Oral SuspensionSCD3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
308459azithromycin 100 MG per 5 ML Oral SuspensionSY3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
308459azithromycin 100 MG per 5 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 200 MG per 5 ML Oral SuspensionSY3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
141963azithromycin 200 MG per 5 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 600 MG per 15 ML Oral SuspensionSY3209b147-11ce-4eeb-8427-5f8e6fb2c83d16
141963azithromycin 600 MG per 15 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
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
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN2b821631-0df2-0fb2-e054-00144ff8d46c4
308459azithromycin 20 MG/ML Oral SuspensionSCD2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 40 MG/ML Oral SuspensionSCD2b821631-0df2-0fb2-e054-00144ff8d46c4
308459azithromycin 100 MG per 5 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 200 MG per 5 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
141963azithromycin 600 MG per 15 ML Oral SuspensionSY2b821631-0df2-0fb2-e054-00144ff8d46c4
308459azithromycin 100 MG in 5 mL Oral SuspensionPSNac327054-21ab-401c-a27a-48259db18f893
308459azithromycin 20 MG/ML Oral SuspensionSCDac327054-21ab-401c-a27a-48259db18f893
308459azithromycin 100 MG per 5 ML Oral SuspensionSYac327054-21ab-401c-a27a-48259db18f893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-2027-230009320272315 mL in 1 BOTTLE (0093-2027-23) 15 ml2010-12-280000-00-00NoNoCurrent