FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
51224-022
11-digit product format
512240022
Labeler code
51224
Product ID
51224-022_a32e11e0-ff6b-486a-a8af-0d029934b24d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
2026-11-30
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 749783

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
51224-022-06EA - Each51224-0220cfd425d-539a-468c-98e3-54b7cc23dcfc12019-09-05
51224-022-18EA - Each51224-0226cc72b71-963e-47fe-ba39-7879342c07f312019-09-05
51224-022-30EA - Each51224-0220d8cf2fb-9ea4-475f-8dd8-9e6239c708e312019-09-05
51224-022-50EA - Each51224-022ae481c01-f6ab-434d-9469-a920ac44ddf312021-02-05
51224-022-60EA - Each51224-022a9e4ccc4-d955-4a84-9563-9aaa02f9cb9812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-022AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [TAGI PHARMA, INC.]3Current NDC, Legacy NDC20250312_9f0501bf-d1c4-46a5-b253-3b9e61015e82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNdf9b39b7-d42d-4c4b-b492-9fd228978dec17
308460azithromycin 250 MG Oral TabletSCDdf9b39b7-d42d-4c4b-b492-9fd228978dec17
308460azithromycin 250 MG Oral TabletPSN1c84a68b-3eaa-4dab-b5e5-e195c7652e6710
308460azithromycin 250 MG Oral TabletSCD1c84a68b-3eaa-4dab-b5e5-e195c7652e6710
308460azithromycin 250 MG Oral TabletPSNe9800bbe-e8bf-4689-a8a5-dc23b5d2ee569
308460azithromycin 250 MG Oral TabletSCDe9800bbe-e8bf-4689-a8a5-dc23b5d2ee569
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK9f0501bf-d1c4-46a5-b253-3b9e61015e823
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf1752913-85ac-01fa-e053-2995a90a2bd83
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK8037c6f4-4881-4740-8229-2aee56141cd03
308460azithromycin 250 MG Oral TabletPSNf1752913-85ac-01fa-e053-2995a90a2bd83
308460azithromycin 250 MG Oral TabletPSN8037c6f4-4881-4740-8229-2aee56141cd03
308460azithromycin 250 MG Oral TabletPSN9f0501bf-d1c4-46a5-b253-3b9e61015e823
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN9f0501bf-d1c4-46a5-b253-3b9e61015e823
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN8037c6f4-4881-4740-8229-2aee56141cd03
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf1752913-85ac-01fa-e053-2995a90a2bd83
308460azithromycin 250 MG Oral TabletSCD8037c6f4-4881-4740-8229-2aee56141cd03
308460azithromycin 250 MG Oral TabletSCD9f0501bf-d1c4-46a5-b253-3b9e61015e823
308460azithromycin 250 MG Oral TabletSCDf1752913-85ac-01fa-e053-2995a90a2bd83
749783azithromycin 250 MG Oral Tablet 6 Count PackSY8037c6f4-4881-4740-8229-2aee56141cd03
749783azithromycin 250 MG Oral Tablet 6 Count PackSY9f0501bf-d1c4-46a5-b253-3b9e61015e823
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf1752913-85ac-01fa-e053-2995a90a2bd83
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf241b712-d563-45da-8708-8c291abb3b2d2
308460azithromycin 250 MG Oral TabletPSNf241b712-d563-45da-8708-8c291abb3b2d2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf241b712-d563-45da-8708-8c291abb3b2d2
308460azithromycin 250 MG Oral TabletSCDf241b712-d563-45da-8708-8c291abb3b2d2
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf241b712-d563-45da-8708-8c291abb3b2d2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKb08bd8fc-20da-4623-9211-ae669452b16d1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKedb07524-489a-788e-e053-2a95a90a0eea1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK1d87d817-3fa7-e969-e063-6394a90a13ee1
308460azithromycin 250 MG Oral TabletPSNedb07524-489a-788e-e053-2a95a90a0eea1
308460azithromycin 250 MG Oral TabletPSN1d87d817-3fa7-e969-e063-6394a90a13ee1
308460azithromycin 250 MG Oral TabletPSNb08bd8fc-20da-4623-9211-ae669452b16d1
308460azithromycin 250 MG Oral TabletPSN99eb5289-dc06-4594-bdd7-83493d469f821
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNedb07524-489a-788e-e053-2a95a90a0eea1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN1d87d817-3fa7-e969-e063-6394a90a13ee1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNb08bd8fc-20da-4623-9211-ae669452b16d1
308460azithromycin 250 MG Oral TabletSCDedb07524-489a-788e-e053-2a95a90a0eea1
308460azithromycin 250 MG Oral TabletSCDb08bd8fc-20da-4623-9211-ae669452b16d1
308460azithromycin 250 MG Oral TabletSCD1d87d817-3fa7-e969-e063-6394a90a13ee1
308460azithromycin 250 MG Oral TabletSCD99eb5289-dc06-4594-bdd7-83493d469f821
749783azithromycin 250 MG Oral Tablet 6 Count PackSY1d87d817-3fa7-e969-e063-6394a90a13ee1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYedb07524-489a-788e-e053-2a95a90a0eea1
749783azithromycin 250 MG Oral Tablet 6 Count PackSYb08bd8fc-20da-4623-9211-ae669452b16d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-022-06512240022061 BLISTER PACK in 1 CARTON (51224-022-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-07-012026-10-31NoNoCurrent
51224-022-18512240022183 CARTON in 1 BOX (51224-022-18) / 1 BLISTER PACK in 1 CARTON (51224-022-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK3 carton2019-07-012026-10-31NoNoCurrent
51224-022-305122400223030 TABLET, FILM COATED in 1 BOTTLE (51224-022-30) 2019-07-012026-11-30NoNoCurrent
51224-022-5051224002250100 TABLET, FILM COATED in 1 BOTTLE (51224-022-50) 2020-09-010000-00-00NoNoCurrent
51224-022-6051224002260500 TABLET, FILM COATED in 1 BOTTLE (51224-022-60) 2020-09-010000-00-00NoNoCurrent