FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
72789-081
11-digit product format
727890081
Labeler code
72789
Product ID
72789-081_31442118-2505-0be0-e063-6294a90a12d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
2026-11-30
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460

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
72789-081-04Azithromycin Dihydrate4 in 1 BOTTLE, PLASTICTABLET, FILM COATED49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-081AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20250328_e9800bbe-e8bf-4689-a8a5-dc23b5d2ee56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNe9800bbe-e8bf-4689-a8a5-dc23b5d2ee569
308460azithromycin 250 MG Oral TabletSCDe9800bbe-e8bf-4689-a8a5-dc23b5d2ee569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-081-02727890081022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-081-02) 2020-09-140000-00-00NoNoCurrent
72789-081-04727890081044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-081-04) 2020-05-072026-11-30NoNoCurrent