FDA.reportPublic FDA data

Azithromycin

Product NDC
69452-171
11-digit product format
694520171
Labeler code
69452
Product ID
69452-171_4526a56d-6695-5338-e063-6294a90aa2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA210000
Marketing category
ANDA
Marketing start
2019-03-12
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
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
69452-171-04Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED67
69452-171-04Azithromycin1 in 1 CARTONTABLET, FILM COATED17
69452-171-13Azithromycin30 in 1 BOTTLETABLET, FILM COATED307
69452-171-73Azithromycin3 in 1 CARTONTABLET, FILM COATED37
69452-171-73Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-171AZITHROMYCIN 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
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
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 PackPSN859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
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 TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletSCD859bb02c-a4bc-46fa-9fc9-def1219b5dfb7
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
308460azithromycin 250 MG Oral TabletPSNb0138503-ddc4-2e1c-e053-2995a90a0d2d3
308460azithromycin 250 MG Oral TabletSCDb0138503-ddc4-2e1c-e053-2995a90a0d2d3
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK99ca0089-14a9-446d-8807-253ad5be3efa2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK90ff7cfc-73c9-4d77-83df-c05cfbbbbecd2
308460azithromycin 250 MG Oral TabletPSN99ca0089-14a9-446d-8807-253ad5be3efa2
308460azithromycin 250 MG Oral TabletPSN90ff7cfc-73c9-4d77-83df-c05cfbbbbecd2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN99ca0089-14a9-446d-8807-253ad5be3efa2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN90ff7cfc-73c9-4d77-83df-c05cfbbbbecd2
308460azithromycin 250 MG Oral TabletSCD99ca0089-14a9-446d-8807-253ad5be3efa2
308460azithromycin 250 MG Oral TabletSCD90ff7cfc-73c9-4d77-83df-c05cfbbbbecd2
749783azithromycin 250 MG Oral Tablet 6 Count PackSY99ca0089-14a9-446d-8807-253ad5be3efa2
749783azithromycin 250 MG Oral Tablet 6 Count PackSY90ff7cfc-73c9-4d77-83df-c05cfbbbbecd2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK1e1d5d15-bd87-a3ca-e063-6294a90a7f5e1
308460azithromycin 250 MG Oral TabletPSNaf720986-48a9-48b5-bdd7-370f6a2f92e11
308460azithromycin 250 MG Oral TabletPSN1e1d5d15-bd87-a3ca-e063-6294a90a7f5e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN1e1d5d15-bd87-a3ca-e063-6294a90a7f5e1
308460azithromycin 250 MG Oral TabletSCD1e1d5d15-bd87-a3ca-e063-6294a90a7f5e1
308460azithromycin 250 MG Oral TabletSCDaf720986-48a9-48b5-bdd7-370f6a2f92e11
749783azithromycin 250 MG Oral Tablet 6 Count PackSY1e1d5d15-bd87-a3ca-e063-6294a90a7f5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-171-04694520171041 BLISTER PACK in 1 CARTON (69452-171-04) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-10-100000-00-00NoNoCurrent
69452-171-136945201711330 TABLET, FILM COATED in 1 BOTTLE (69452-171-13) 2019-03-120000-00-00NoNoCurrent
69452-171-73694520171733 BLISTER PACK in 1 CARTON (69452-171-73) / 6 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2019-10-100000-00-00NoNoCurrent
69452-171-996945201719921000 TABLET, FILM COATED in 1 DRUM (69452-171-99)17-AUG-22Current