FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68071-3661
11-digit product format
680713661
Labeler code
68071
Product ID
68071-3661_51b56053-28e0-9bdb-e063-6394a90ac375
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2024-02-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
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 Dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3661-2Azithromycin Dihydrate2 in 1 BOTTLETABLET, FILM COATED22
68071-3661-6Azithromycin Dihydrate6 in 1 BOTTLETABLET, FILM COATED62
68071-3661-7Azithromycin Dihydrate7 in 1 BOTTLETABLET, FILM COATED72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3661AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 3 package rows20240912_21c67de0-3a4e-caab-e063-6394a90ae3cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN21c67de0-3a4e-caab-e063-6394a90ae3cd2
248656azithromycin 500 MG Oral TabletSCD21c67de0-3a4e-caab-e063-6394a90ae3cd2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY21c67de0-3a4e-caab-e063-6394a90ae3cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3661-2680713661022 TABLET, FILM COATED in 1 BOTTLE (68071-3661-2) 2024-09-10NoNoHistorical
68071-3661-6680713661066 TABLET, FILM COATED in 1 BOTTLE (68071-3661-6) 2024-09-10NoNoHistorical
68071-3661-7680713661077 TABLET, FILM COATED in 1 BOTTLE (68071-3661-7) 2026-05-13NoNoHistorical