FDA.reportPublic FDA data

Azithromycin

Product NDC
71205-519
11-digit product format
712050519
Labeler code
71205
Product ID
71205-519_8a140f7c-4dc7-454d-9ff9-473f4306a649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 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 DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656, 749780

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
71205-519-03Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED32
71205-519-03Azithromycin1 in 1 CARTONTABLET, FILM COATED12
71205-519-30Azithromycin30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-519-03EA - Each71205-5190a060cda-733a-4be3-bb1d-e7b58eafe9f612021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-519AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220413_25f2d819-ae38-4061-a897-bbcfce3739bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG Oral TabletPSN25f2d819-ae38-4061-a897-bbcfce3739bf2
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG Oral TabletSCD25f2d819-ae38-4061-a897-bbcfce3739bf2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY25f2d819-ae38-4061-a897-bbcfce3739bf2
749780azithromycin 500 MG Oral Tablet 3 Count PackSY25f2d819-ae38-4061-a897-bbcfce3739bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-519-03712050519031 BLISTER PACK in 1 CARTON (71205-519-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-01-040000-00-00NoNoCurrent
71205-519-307120505193030 TABLET, FILM COATED in 1 BOTTLE (71205-519-30) 2021-01-040000-00-00NoNoCurrent