Azithromycin Dihydrate

Product NDC
72789-066
11-digit product format
727890066
Labeler code
72789
Product ID
72789-066_e61084f0-edd8-96cb-e053-2995a90a50d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-066-02EA - Each72789-0663e130749-ef01-46c2-91f7-5a22fb4fa0e512020-05-08
72789-066-03EA - Each72789-06664bd5380-8c9a-46da-acfd-bdb91611cf3712020-07-13
72789-066-07EA - Each72789-0669164e5ab-dc96-422b-8826-a93a8408283d12020-07-13
72789-066-79EA - Each72789-066d2bc9833-92a1-4fc6-962b-d1aae666e50312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-066AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12Legacy NDC20250502_d07bb450-f0ac-4faa-8289-9d4e45bb0a88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-066-02727890066022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-02) 2020-03-230000-00-00NoNoCurrent
72789-066-03727890066033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-03) 2020-04-200000-00-00NoNoCurrent
72789-066-07727890066077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-07) 2019-07-010000-00-00NoNoCurrent
72789-066-79727890066791 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-79) 2020-03-300000-00-00NoNoCurrent