Azithromycin

Product NDC
71205-645
11-digit product format
712050645
Labeler code
71205
Product ID
71205-645_8e6754bd-b54c-41db-ae4b-a69b9f8424d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
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, 749783

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
71205-645-06Azithromycin1 in 1 DOSE PACKTABLET, FILM COATED13
71205-645-06Azithromycin6 in 1 CARTONTABLET, FILM COATED63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-645-06EA - Each71205-6455c34bb31-b5e2-4a63-beba-6903fd32feca12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-645AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 2 package rows20241031_38942011-f86b-4e42-a4ca-05a70d9dd3d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN38942011-f86b-4e42-a4ca-05a70d9dd3d93
308460azithromycin 250 MG Oral TabletSCD38942011-f86b-4e42-a4ca-05a70d9dd3d93
749783azithromycin 250 MG Oral Tablet 6 Count PackSY38942011-f86b-4e42-a4ca-05a70d9dd3d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-645-06712050645066 DOSE PACK in 1 CARTON (71205-645-06) / 1 TABLET, FILM COATED in 1 DOSE PACK6 dose pack2022-03-180000-00-00NoNoCurrent