Azithromycin

Product NDC
0781-1496
11-digit product format
007811496
Labeler code
0781
Product ID
0781-1496_fe925fb2-7067-4951-a3b3-93296689e550
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065211
Marketing category
ANDA
Marketing start
2005-11-14
Marketing end
2020-09-30
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1496-31EA - Each0781-1496bf8085d1-664a-4424-ba26-e01b047a55f312012-07-24
0781-1496-68EA - Each0781-14966f567724-62f7-4af3-9efb-aa149bad2e7712012-07-24
0781-1496-69EA - Each0781-1496fd91bfa6-30db-4afd-94c2-c52c214ad08f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCINACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN7f6c0f30-2f11-4d08-b478-3ff5e170511910
308460azithromycin 250 MG Oral TabletSCD7f6c0f30-2f11-4d08-b478-3ff5e170511910
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4a13b574-ff5e-417e-bef4-279fcc3d52803
308460azithromycin 250 MG Oral TabletPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG Oral TabletPSN4a13b574-ff5e-417e-bef4-279fcc3d52803
308460azithromycin 250 MG Oral TabletSCD00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
308460azithromycin 250 MG Oral TabletSCD4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG Oral TabletSCD4a13b574-ff5e-417e-bef4-279fcc3d52803
749783azithromycin 250 MG Oral Tablet 6 Count PackSY00a7dad6-0bfc-4ccc-b261-3e0004b4c6593
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4a13b574-ff5e-417e-bef4-279fcc3d52803
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4a13b574-ff5e-417e-bef4-279fcc3d52803
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletPSN4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN4ece67c7-b351-48bf-8488-8238279522721
308460azithromycin 250 MG Oral TabletSCD10aebebe-98b3-4f35-b9cb-dba5e3505f1e1
308460azithromycin 250 MG Oral TabletSCD4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackSY4ece67c7-b351-48bf-8488-8238279522721
749783azithromycin 250 MG Oral Tablet 6 Count PackSY10aebebe-98b3-4f35-b9cb-dba5e3505f1e1