azithromycin

Product NDC
68180-863
11-digit product format
681800863
Labeler code
68180
Product ID
68180-863_f00d46cd-d46a-44de-94ad-7e0e811b23af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065400
Marketing category
ANDA
Marketing start
2022-11-17
Substance
AZITHROMYCIN DIHYDRATE
Active strength
600 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui204844

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
68180-863-06azithromycin30 in 1 CONTAINERTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-863-06EA - Each68180-863dcb9d07e-dbd0-4c29-acb9-604c89f5c56212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-863AZITHROMYCIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20250501_c9990a1d-5238-403e-9221-72a9314d7b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204844azithromycin 600 MG Oral TabletPSNc9990a1d-5238-403e-9221-72a9314d7b5e4
204844azithromycin 600 MG Oral TabletSCDc9990a1d-5238-403e-9221-72a9314d7b5e4
204844azithromycin 600 MG Oral TabletPSN2cc93e72-95ce-965b-e063-6394a90a89171
204844azithromycin 600 MG Oral TabletSCD2cc93e72-95ce-965b-e063-6394a90a89171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-863-066818008630630 TABLET, FILM COATED in 1 CONTAINER (68180-863-06) 2022-11-170000-00-00NoNoCurrent