FDA.reportPublic FDA data

Azithromycin Monohydrate

Product NDC
69677-129
11-digit product format
696770129
Labeler code
69677
Product ID
69677-129_62d64414-d3ac-1741-e053-2a91aa0ac0f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Monohydrate
Dosage form
TABLET
Route
ORAL
Labeler
MAS MANAGEMENT GROUP, INC.
Application
ANDA065398
Marketing category
ANDA
Marketing start
2015-08-18
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
69677-129-062020-01-31C16284748780-19d75b9cf-f9d1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
69677-129-302020-01-31C16284748780-19d75b9cf-f9d1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69677-129-06Azithromycin Monohydrate6 in 1 BLISTER PACKTABLET61
69677-129-30Azithromycin Monohydrate30 in 1 CONTAINERTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69677-129-06EA - Each69677-129a178a686-c7cb-4258-aa30-665d7a84f46412018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-129AZITHROMYCIN MONOHYDRATE TABLET [MAS MANAGEMENT GROUP, INC.]1Legacy NDC, 2 package rows20180330_62d64414-d3ab-1741-e053-2a91aa0ac0f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK62d64414-d3ab-1741-e053-2a91aa0ac0f81
308460azithromycin 250 MG Oral TabletPSN62d64414-d3ab-1741-e053-2a91aa0ac0f81
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN62d64414-d3ab-1741-e053-2a91aa0ac0f81
308460azithromycin 250 MG Oral TabletSCD62d64414-d3ab-1741-e053-2a91aa0ac0f81
749783azithromycin 250 MG Oral Tablet 6 Count PackSY62d64414-d3ab-1741-e053-2a91aa0ac0f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69677-129-06696770129066 in 1 BLISTER PACKHistorical
69677-129-306967701293030 in 1 CONTAINERHistorical