Azithromycin Dihydrate

Product NDC
67296-2185
11-digit product format
672962185
Labeler code
67296
Product ID
67296-2185_44f52dd3-7dc9-93e1-e063-6294a90acdeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA208250
Marketing category
ANDA
Marketing start
2024-02-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 749783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2185-6Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED11
67296-2185-6Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK44f52ce0-ad3f-7d80-e063-6294a90ad0861
308460azithromycin 250 MG Oral TabletPSN44f52ce0-ad3f-7d80-e063-6294a90ad0861
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN44f52ce0-ad3f-7d80-e063-6294a90ad0861
308460azithromycin 250 MG Oral TabletSCD44f52ce0-ad3f-7d80-e063-6294a90ad0861
749783azithromycin 250 MG Oral Tablet 6 Count PackSY44f52ce0-ad3f-7d80-e063-6294a90ad0861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2185-6672962185061 BLISTER PACK in 1 CARTON (67296-2185-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-02-15NoNoCurrent