FDA.reportPublic FDA data

azithromycin dihydrate

Product NDC
70436-221
11-digit product format
704360221
Labeler code
70436
Product ID
70436-221_32f66ed6-7a90-559b-e063-6394a90aaf93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217036
Marketing category
ANDA
Marketing start
2024-01-01
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 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 dihydrate
Listing expiration
2026-12-31

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
70436-221-34azithromycin dihydrate15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION156
70436-221-34azithromycin dihydrate1 in 1 CARTONPOWDER, FOR SUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-221-34ML - Milliliter70436-221a832d121-7dd4-4348-8140-9a7d351cca1712024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-221AZITHROMYCIN DIHYDRATE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC]6Current NDC, 2 package rows20250418_33d4ac05-b564-440c-971d-b78590dd2c32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN33d4ac05-b564-440c-971d-b78590dd2c326
308459azithromycin 20 MG/ML Oral SuspensionSCD33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 40 MG/ML Oral SuspensionSCD33d4ac05-b564-440c-971d-b78590dd2c326
308459azithromycin 100 MG per 5 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 200 MG per 5 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 600 MG per 15 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-221-34704360221341 BOTTLE in 1 CARTON (70436-221-34) / 15 mL in 1 BOTTLE1 bottle2024-01-01NoNoHistorical