FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
51224-122
11-digit product format
512240122
Labeler code
51224
Product ID
51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
2026-10-31
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-122-03EA - Each51224-122d7387dad-eda6-4745-a31f-86bb1c4aaf2f12019-11-12
51224-122-09EA - Each51224-122ec891901-b723-487c-8bbc-09ab88909e0a12019-11-12
51224-122-30EA - Each51224-1229cf42c98-2c92-478f-943c-a284e4f32bdd12019-09-05
51224-122-50EA - Each51224-122a9087574-29d6-4532-9ac7-cad26b13bf3f12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-122AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [TAGI PHARMA, INC.]3Current NDC, Legacy NDC20250313_41e2163b-af61-4323-8b9c-2d44fc122fd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNc7ed6985-1d1d-48af-9df8-64b12821789e10
248656azithromycin 500 MG Oral TabletSCDc7ed6985-1d1d-48af-9df8-64b12821789e10
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYc7ed6985-1d1d-48af-9df8-64b12821789e10
308460azithromycin 250 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
308460azithromycin 250 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletPSN0494df57-f514-4274-8e38-dd79023fedb06
248656azithromycin 500 MG Oral TabletSCD0494df57-f514-4274-8e38-dd79023fedb06
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY0494df57-f514-4274-8e38-dd79023fedb06
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG Oral TabletPSN0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG Oral TabletPSNfe52f9fe-da0f-47e5-899e-a5513fb7688d5
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG Oral TabletSCDfe52f9fe-da0f-47e5-899e-a5513fb7688d5
248656azithromycin 500 MG Oral TabletSCD0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY0f36ba37-a742-41c1-ad2d-b890a1d49c555
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYfe52f9fe-da0f-47e5-899e-a5513fb7688d5
749780azithromycin 500 MG Oral Tablet 3 Count PackSY0f36ba37-a742-41c1-ad2d-b890a1d49c555
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG Oral TabletPSNa6426d5f-5518-3c69-e053-2995a90af50f4
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG Oral TabletSCDa6426d5f-5518-3c69-e053-2995a90af50f4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa6426d5f-5518-3c69-e053-2995a90af50f4
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa6426d5f-5518-3c69-e053-2995a90af50f4
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK41e2163b-af61-4323-8b9c-2d44fc122fd93
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf1755cf3-bf7f-be40-e053-2a95a90a85363
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKbb97a057-2537-41ae-b50c-a80605039c303
248656azithromycin 500 MG Oral TabletPSNf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG Oral TabletPSN00dab70c-53ab-4a08-a6f0-1d78cbe439263
248656azithromycin 500 MG Oral TabletPSNe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG Oral TabletPSN41e2163b-af61-4323-8b9c-2d44fc122fd93
248656azithromycin 500 MG Oral TabletPSNbb97a057-2537-41ae-b50c-a80605039c303
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNbb97a057-2537-41ae-b50c-a80605039c303
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN41e2163b-af61-4323-8b9c-2d44fc122fd93
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG Oral TabletSCD00dab70c-53ab-4a08-a6f0-1d78cbe439263
248656azithromycin 500 MG Oral TabletSCDbb97a057-2537-41ae-b50c-a80605039c303
248656azithromycin 500 MG Oral TabletSCDe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG Oral TabletSCD41e2163b-af61-4323-8b9c-2d44fc122fd93
248656azithromycin 500 MG Oral TabletSCDf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY41e2163b-af61-4323-8b9c-2d44fc122fd93
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY00dab70c-53ab-4a08-a6f0-1d78cbe439263
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYbb97a057-2537-41ae-b50c-a80605039c303
749780azithromycin 500 MG Oral Tablet 3 Count PackSY41e2163b-af61-4323-8b9c-2d44fc122fd93
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf1755cf3-bf7f-be40-e053-2a95a90a85363
749780azithromycin 500 MG Oral Tablet 3 Count PackSYe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
749780azithromycin 500 MG Oral Tablet 3 Count PackSYbb97a057-2537-41ae-b50c-a80605039c303
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf4c1ca07-7130-66fb-e053-2995a90ad5dc2
248656azithromycin 500 MG Oral TabletPSNf4c1ca07-7130-66fb-e053-2995a90ad5dc2
248656azithromycin 500 MG Oral TabletPSNe2ad6eff-97ff-135a-e053-2a95a90afed52
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf4c1ca07-7130-66fb-e053-2995a90ad5dc2
248656azithromycin 500 MG Oral TabletSCDe2ad6eff-97ff-135a-e053-2a95a90afed52
248656azithromycin 500 MG Oral TabletSCDf4c1ca07-7130-66fb-e053-2995a90ad5dc2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYe2ad6eff-97ff-135a-e053-2a95a90afed52
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf4c1ca07-7130-66fb-e053-2995a90ad5dc2
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf4c1ca07-7130-66fb-e053-2995a90ad5dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-122-03512240122031 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-07-012026-05-31NoNoCurrent
51224-122-09512240122093 CARTON in 1 BOX (51224-122-09) / 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK3 carton2019-07-012026-10-31NoNoCurrent
51224-122-305122401223030 TABLET, FILM COATED in 1 BOTTLE (51224-122-30) 2019-07-012026-10-31NoNoCurrent
51224-122-5051224012250100 TABLET, FILM COATED in 1 BOTTLE (51224-122-50) 2020-09-010000-00-00NoNoCurrent