Azithromycin

Product NDC
69452-173
11-digit product format
694520173
Labeler code
69452
Product ID
69452-173_0d48a6b6-8e7f-a3ae-e063-6394a90ada0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209999
Marketing category
ANDA
Marketing start
2018-12-26
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui204844

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
69452-173-13Azithromycin30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-173-13EA - Each69452-173cb0a91b7-5943-4e90-bfd5-4763da81d2ec12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-173AZITHROMYCIN TABLET, FILM COATED [BIONPHARMA INC.]8Current NDC, Legacy NDC, 1 package rows20231225_a2754618-3df1-4b89-aa09-fdff4b71b7e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSNa2754618-3df1-4b89-aa09-fdff4b71b7e48
204844azithromycin 600 MG Oral TabletSCDa2754618-3df1-4b89-aa09-fdff4b71b7e48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-173-136945201731330 TABLET, FILM COATED in 1 BOTTLE (69452-173-13) 2018-12-260000-00-00NoNoCurrent