FDA.reportPublic FDA data

Azithromycin

Product NDC
70518-0599
11-digit product format
705180599
Labeler code
70518
Product ID
70518-0599_47fa21e2-07c3-16d5-e063-6394a90abf0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065223
Marketing category
ANDA
Marketing start
2017-06-28
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui248656

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
70518-0599-02021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-02021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-12021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-12021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-22021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-22021-04-05C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-02020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-02020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-12020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-12020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-22020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991
70518-0599-22020-01-31C16284748780-19d75b9d0-a9ff-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, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0599-0Azithromycin2 in 1 BOXTABLET, FILM COATED217
70518-0599-1Azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-0599-2Azithromycin3 in 1 BOTTLE, PLASTICTABLET, FILM COATED317
70518-0599-3Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
70518-0599-4Azithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2017
70518-0599-5Azithromycin2 in 1 BOTTLE, PLASTICTABLET, FILM COATED217
70518-0599-6Azithromycin1 in 1 POUCHTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0599-0EA - Each70518-05993961efc5-a6ea-4aa3-a357-d347890a018912026-01-08
70518-0599-3EA - Each70518-0599bdc608e8-c4d3-4711-aa90-9796c683af5612026-01-08
70518-0599-6EA - Each70518-0599fefaa58b-ae47-4163-b5f6-d7908f41ef1812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0599AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 7 package rows20250429_943b9246-7733-44b1-875c-91d2ade78ac4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG Oral TabletSCD943b9246-7733-44b1-875c-91d2ade78ac417
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY943b9246-7733-44b1-875c-91d2ade78ac417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0599-0705180599002 POUCH in 1 BOX (70518-0599-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-0599-6) 2 pouch2017-06-280000-00-00NoNoCurrent
70518-0599-17051805990130 TABLET, FILM COATED in 1 BLISTER PACK (70518-0599-1) 2017-11-150000-00-00NoNoCurrent
70518-0599-2705180599023 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-2) 2018-05-140000-00-00NoNoCurrent
70518-0599-3705180599032 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-3) 2020-04-230000-00-00NoNoCurrent
70518-0599-47051805990420 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-4) 2021-01-210000-00-00NoNoCurrent
70518-0599-5705180599052 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0599-5) 2021-05-030000-00-00NoNoCurrent
70518-0599-6705180599061 in 1 POUCHHistorical