FDA.reportPublic FDA data

AZITHROMYCIN

Product NDC
68258-3012
11-digit product format
682583012
Labeler code
68258
Product ID
68258-3012_9203a55b-aa44-428c-890a-58208fd01bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions Inc.
Application
ANDA065405
Marketing category
ANDA
Marketing start
2008-05-30
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-3012-12019-10-21C16284748780-1956f9ecf-dd34-621f-e053-dbdaa90a74ad24ea9765-6d74-4681-8110-5a6fc0b04db5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3012-1AZITHROMYCIN3 in 1 BLISTER PACKTABLET, FILM COATED31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-3012-1EA - Each68258-3012aac543fb-1484-413b-bb5a-32e80a902c3012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN ANHYDROUSACTIVE INGREDIENTJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
AZITHROMYCINACTIVE MOIETYF94OW58Y8VAZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3012AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1Legacy NDC, 1 package rows20100224_24ea9765-6d74-4681-8110-5a6fc0b04db5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK24ea9765-6d74-4681-8110-5a6fc0b04db51
248656azithromycin 500 MG Oral TabletPSN24ea9765-6d74-4681-8110-5a6fc0b04db51
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN24ea9765-6d74-4681-8110-5a6fc0b04db51
248656azithromycin 500 MG Oral TabletSCD24ea9765-6d74-4681-8110-5a6fc0b04db51
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY24ea9765-6d74-4681-8110-5a6fc0b04db51
749780azithromycin 500 MG Oral Tablet 3 Count PackSY24ea9765-6d74-4681-8110-5a6fc0b04db51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-3012-1682583012013 in 1 BLISTER PACKHistorical