azithromycin

Generic: azithromycin

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4356
Product ID 70518-4356_40313c7e-999d-e27b-e063-6394a90ac8c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065398
Listing Expiration 2026-12-31
Marketing Start 2025-06-13

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184356
Hyphenated Format 70518-4356

Supplemental Identifiers

RxCUI
308460
UNII
5FD1131I7S

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 BLISTER PACK (70518-4356-0)
source: ndc

Packages (1)

70518-4356-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4356-0)

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": "40313c7e-999d-e27b-e063-6394a90ac8c7", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460"], "spl_set_id": ["da399401-1ee6-422a-be46-0bba6b264b2f"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4356-0)", "package_ndc": "70518-4356-0", "marketing_start_date": "20250613"}], "brand_name": "azithromycin", "product_id": "70518-4356_40313c7e-999d-e27b-e063-6394a90ac8c7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70518-4356", "generic_name": "azithromycin", "labeler_name": "REMEDYREPACK 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": "20250613", "listing_expiration_date": "20261231"}