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 600 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-863
Product ID 68180-863_f00d46cd-d46a-44de-94ad-7e0e811b23af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065400
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 68180863
Hyphenated Format 68180-863

Supplemental Identifiers

RxCUI
204844
UPC
0368180863069
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 ANDA065400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 CONTAINER (68180-863-06)
source: ndc

Packages (1)

68180-863-06 30 TABLET, FILM COATED in 1 CONTAINER (68180-863-06)

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": "f00d46cd-d46a-44de-94ad-7e0e811b23af", "openfda": {"upc": ["0368180863069"], "unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["c9990a1d-5238-403e-9221-72a9314d7b5e"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 CONTAINER (68180-863-06)", "package_ndc": "68180-863-06", "marketing_start_date": "20221117"}], "brand_name": "azithromycin", "product_id": "68180-863_f00d46cd-d46a-44de-94ad-7e0e811b23af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68180-863", "generic_name": "azithromycin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA065400", "marketing_category": "ANDA", "marketing_start_date": "20221117", "listing_expiration_date": "20261231"}