azithromycin

Generic: azithromycin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 250 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-861
Product ID 68180-861_94b31917-601f-41bc-a6c8-2873d5d719a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065398
Listing Expiration 2026-12-31
Marketing Start 2022-11-17

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180861
Hyphenated Format 68180-861

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
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 ANDA065398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 CONTAINER (68180-861-06)
  • 6 TABLET, FILM COATED in 1 BLISTER PACK (68180-861-11)
source: ndc

Packages (2)

68180-861-06 30 TABLET, FILM COATED in 1 CONTAINER (68180-861-06) 68180-861-11 6 TABLET, FILM COATED in 1 BLISTER PACK (68180-861-11)

Ingredients (1)

azithromycin dihydrate (250 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": "94b31917-601f-41bc-a6c8-2873d5d719a6", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["01649d79-4677-4577-a3e4-e054f3f9fc3b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 CONTAINER (68180-861-06)", "package_ndc": "68180-861-06", "marketing_start_date": "20221117"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BLISTER PACK (68180-861-11)", "package_ndc": "68180-861-11", "marketing_start_date": "20221117"}], "brand_name": "azithromycin", "product_id": "68180-861_94b31917-601f-41bc-a6c8-2873d5d719a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68180-861", "generic_name": "azithromycin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065398", "marketing_category": "ANDA", "marketing_start_date": "20221117", "listing_expiration_date": "20261231"}