FDA.reportPublic FDA data

Azithromycin

Product NDC
70518-2433
11-digit product format
705182433
Labeler code
70518
Product ID
70518-2433_50b101e4-e5a0-8ee8-e063-6294a90a6ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207370
Marketing category
ANDA
Marketing start
2019-11-19
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2433-0Azithromycin30 in 1 BLISTER PACKTABLET, FILM COATED3017
70518-2433-1Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED617
70518-2433-2Azithromycin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED617
70518-2433-3Azithromycin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3017
70518-2433-4Azithromycin3 in 1 CARTONTABLET, FILM COATED317
70518-2433-4Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED617
70518-2433-5Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED617
70518-2433-5Azithromycin1 in 1 CARTONTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2433-0EA - Each70518-2433e9257d1e-4afe-40f0-a392-b8beec79c8ae12026-01-08
70518-2433-2EA - Each70518-243305eaffb0-a801-4d32-80e4-ab417f92eeaa12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2433AZITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 8 package rows20250316_5f144e92-c9eb-420a-9bb8-4265a9f20a98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN5f144e92-c9eb-420a-9bb8-4265a9f20a9817
308460azithromycin 250 MG Oral TabletSCD5f144e92-c9eb-420a-9bb8-4265a9f20a9817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2433-07051824330030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2433-0) 2019-11-190000-00-00NoNoCurrent
70518-2433-1705182433016 TABLET, FILM COATED in 1 BLISTER PACK (70518-2433-1) 2019-12-100000-00-00NoNoCurrent
70518-2433-2705182433026 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2433-2) 2020-01-280000-00-00NoNoCurrent
70518-2433-37051824330330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2433-3) 2022-03-290000-00-00NoNoCurrent
70518-2433-4705182433043 in 1 CARTONHistorical
70518-2433-5705182433056 in 1 BLISTER PACKHistorical