Azithromycin

Product NDC
71205-503
11-digit product format
712050503
Labeler code
71205
Product ID
71205-503_31df881c-4b9b-4717-8f76-98b6ca8be644
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210001
Marketing category
ANDA
Marketing start
2019-03-12
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

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
71205-503-03Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED32
71205-503-03Azithromycin1 in 1 BAGTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-503-03EA - Each71205-50325e9f64d-1104-4e4c-8595-5d411fbe7fbc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-503AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 2 package rows20221112_34e6364a-ac3d-434e-a90c-cb13ebcf7983.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN34e6364a-ac3d-434e-a90c-cb13ebcf79832
248656azithromycin 500 MG Oral TabletSCD34e6364a-ac3d-434e-a90c-cb13ebcf79832
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY34e6364a-ac3d-434e-a90c-cb13ebcf79832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-503-03712050503031 BLISTER PACK in 1 BAG (71205-503-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-02-260000-00-00NoNoCurrent