Azithromycin

Product NDC
71205-158
11-digit product format
712050158
Labeler code
71205
Product ID
71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207370
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460

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
71205-158-03Azithromycin3 in 1 BOTTLETABLET, FILM COATED35
71205-158-06Azithromycin6 in 1 BOTTLETABLET, FILM COATED65
71205-158-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED305
71205-158-66Azithromycin1 in 1 CARTONTABLET, FILM COATED15
71205-158-66Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-158AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20220626_cb40f4cf-15ae-47ab-8e0a-979467fa0d9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNcb40f4cf-15ae-47ab-8e0a-979467fa0d9e5
308460azithromycin 250 MG Oral TabletSCDcb40f4cf-15ae-47ab-8e0a-979467fa0d9e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-158-03712050158033 TABLET, FILM COATED in 1 BOTTLE (71205-158-03) 2018-11-010000-00-00NoNoCurrent
71205-158-06712050158066 TABLET, FILM COATED in 1 BOTTLE (71205-158-06) 2018-11-010000-00-00NoNoCurrent
71205-158-307120501583030 TABLET, FILM COATED in 1 BOTTLE (71205-158-30) 2018-11-010000-00-00NoNoCurrent
71205-158-66712050158661 BLISTER PACK in 1 CARTON (71205-158-66) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-12-110000-00-00NoNoCurrent