FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
71205-491
11-digit product format
712050491
Labeler code
71205
Product ID
71205-491_c11b77b5-22be-4867-8752-ffc72a57f768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
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 Dihydrate
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-491-03Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED33
71205-491-04Azithromycin Dihydrate4 in 1 BLISTER PACKTABLET, FILM COATED43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-491-04EA - Each71205-491b9e54dda-9339-4a50-9d6f-7eb3e1a6131312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-491AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 2 package rows20241121_bb97a057-2537-41ae-b50c-a80605039c30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKbb97a057-2537-41ae-b50c-a80605039c303
248656azithromycin 500 MG Oral TabletPSNbb97a057-2537-41ae-b50c-a80605039c303
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNbb97a057-2537-41ae-b50c-a80605039c303
248656azithromycin 500 MG Oral TabletSCDbb97a057-2537-41ae-b50c-a80605039c303
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbb97a057-2537-41ae-b50c-a80605039c303
749780azithromycin 500 MG Oral Tablet 3 Count PackSYbb97a057-2537-41ae-b50c-a80605039c303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-491-03712050491033 TABLET, FILM COATED in 1 BLISTER PACK (71205-491-03) 2020-10-160000-00-00NoNoCurrent
71205-491-04712050491044 TABLET, FILM COATED in 1 BLISTER PACK (71205-491-04) 2024-11-12NoNoCurrent