FDA.reportPublic FDA data

Azithromycin

Product NDC
11788-129
11-digit product format
117880129
Labeler code
11788
Product ID
11788-129_b4d8ea81-97cd-4aeb-a1a9-48e3f8587356
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA217036
Marketing category
ANDA
Marketing start
2026-01-16
Substance
AZITHROMYCIN DIHYDRATE
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 DIHYDRATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
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
11788-129-13Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION11
11788-129-13Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION151
11788-129-14Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.51
11788-129-14Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION11
11788-129-15Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION11
11788-129-15Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-129-13ML - Milliliter11788-129f4c9f925-351b-4766-b98b-9a8699b871ed12026-03-17
11788-129-14ML - Milliliter11788-1293941c588-30bd-4280-9d47-4efb7750191f12026-03-17
11788-129-15ML - Milliliter11788-129dbd5c695-53db-49a4-a174-105ea9b1630a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSNd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
308459azithromycin 20 MG/ML Oral SuspensionSCDd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
141963azithromycin 40 MG/ML Oral SuspensionSCDd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
308459azithromycin 100 MG per 5 ML Oral SuspensionSYd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
141963azithromycin 200 MG per 5 ML Oral SuspensionSYd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1
141963azithromycin 600 MG per 15 ML Oral SuspensionSYd6fb42ed-7dac-4a7b-9964-d367dd47dd5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-129-13117880129131 BOTTLE in 1 CARTON (11788-129-13) / 15 mL in 1 BOTTLE1 bottle2026-01-16NoNoCurrent
11788-129-14117880129141 BOTTLE in 1 CARTON (11788-129-14) / 22.5 mL in 1 BOTTLE1 bottle2026-01-16NoNoCurrent
11788-129-15117880129151 BOTTLE in 1 CARTON (11788-129-15) / 30 mL in 1 BOTTLE1 bottle2026-01-16NoNoCurrent