azithromycin

Generic: azithromycin

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler sandoz inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 600 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-8091
Product ID 0781-8091_5cec3961-a2a4-4f61-a73e-1656021b4195
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065209
Listing Expiration 2026-12-31
Marketing Start 2005-11-14

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07818091
Hyphenated Format 0781-8091

Supplemental Identifiers

RxCUI
204844
UNII
5FD1131I7S

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name azithromycin (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA065209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31)
source: ndc

Packages (1)

0781-8091-31 30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31)

Ingredients (1)

azithromycin dihydrate (600 mg/1)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5cec3961-a2a4-4f61-a73e-1656021b4195", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["34b70c23-92a6-460f-8dbb-15a0e6b9d3a9"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31)", "package_ndc": "0781-8091-31", "marketing_start_date": "20190214"}], "brand_name": "Azithromycin", "product_id": "0781-8091_5cec3961-a2a4-4f61-a73e-1656021b4195", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "0781-8091", "generic_name": "Azithromycin", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA065209", "marketing_category": "ANDA", "marketing_start_date": "20051114", "listing_expiration_date": "20261231"}