FDA.reportPublic FDA data

Azithromycin

Product NDC
69452-172
11-digit product format
694520172
Labeler code
69452
Product ID
69452-172_4526a56d-6695-5338-e063-6294a90aa2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
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, 308460, 749780, 749783

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
69452-172-13Azithromycin30 in 1 BOTTLETABLET, FILM COATED307
69452-172-72Azithromycin3 in 1 CARTONTABLET, FILM COATED37
69452-172-72Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED37
69452-172-74Azithromycin1 in 1 CARTONTABLET, FILM COATED17
69452-172-74Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-172-13EA - Each69452-172a8208acb-1c0e-4c24-8b70-3f88492f875f12019-06-19
69452-172-72EA - Each69452-172f0fff21a-e0f5-4800-8ec4-e9fd6ef9d59a12019-11-12
69452-172-74EA - Each69452-1726922a1b1-13af-45a1-bf11-3636318606f712019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-172AZITHROMYCIN TABLET, FILM COATED [BIONPHARMA INC.]6Current NDC, Legacy NDC, 5 package rows20241212_859bb02c-a4bc-46fa-9fc9-def1219b5dfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNb5d79719-b1dc-469f-a19c-f8ba615138f0103
248656azithromycin 500 MG Oral TabletSCDb5d79719-b1dc-469f-a19c-f8ba615138f0103
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb5d79719-b1dc-469f-a19c-f8ba615138f0103
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
308460azithromycin 250 MG Oral TabletPSN859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
308460azithromycin 250 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
248656azithromycin 500 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletPSN859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
308460azithromycin 250 MG Oral TabletSCD859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
308460azithromycin 250 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCD859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749783azithromycin 250 MG Oral Tablet 6 Count PackSY859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackSY859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG Oral TabletPSNdc633b7d-5154-7e43-e053-2a95a90ad2a64
308460azithromycin 250 MG Oral TabletSCDdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG Oral TabletSCDdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYdc633b7d-5154-7e43-e053-2a95a90ad2a64
248656azithromycin 500 MG Oral TabletPSNb43d23c7-1a2e-ce93-e053-2995a90a65a43
248656azithromycin 500 MG Oral TabletSCDb43d23c7-1a2e-ce93-e053-2995a90a65a43
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb43d23c7-1a2e-ce93-e053-2995a90a65a43
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
248656azithromycin 500 MG Oral TabletPSN1e1d6592-562f-56cc-e063-6394a90aa5301
248656azithromycin 500 MG Oral TabletSCD1e1d6592-562f-56cc-e063-6394a90aa5301
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY1e1d6592-562f-56cc-e063-6394a90aa5301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-172-136945201721330 TABLET, FILM COATED in 1 BOTTLE (69452-172-13) 2019-03-120000-00-00NoNoCurrent
69452-172-72694520172723 BLISTER PACK in 1 CARTON (69452-172-72) / 3 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2019-10-100000-00-00NoNoCurrent
69452-172-74694520172741 BLISTER PACK in 1 CARTON (69452-172-74) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-10-100000-00-00NoNoCurrent