azithromycin

Generic: azithromycin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-058
Product ID 46708-058_ea5ea4f7-a4ce-4644-860a-942898f50a8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211792
Listing Expiration 2026-12-31
Marketing Start 2020-01-29

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708058
Hyphenated Format 46708-058

Supplemental Identifiers

RxCUI
248656 749780
UPC
0346708058302
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 ANDA211792 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (46708-058-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-058-30)
source: ndc

Packages (2)

46708-058-03 3 BLISTER PACK in 1 CARTON (46708-058-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 46708-058-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-058-30)

Ingredients (1)

azithromycin dihydrate (500 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": "ea5ea4f7-a4ce-4644-860a-942898f50a8a", "openfda": {"upc": ["0346708058302"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["d5c95c30-564f-4b67-ac6d-9179cdfaa5a8"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (46708-058-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-058-03", "marketing_start_date": "20200129"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-058-30)", "package_ndc": "46708-058-30", "marketing_start_date": "20200129"}], "brand_name": "Azithromycin", "product_id": "46708-058_ea5ea4f7-a4ce-4644-860a-942898f50a8a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "46708-058", "generic_name": "Azithromycin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA211792", "marketing_category": "ANDA", "marketing_start_date": "20200129", "listing_expiration_date": "20261231"}