azithromycin

Generic: azithromycin monohydrate

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

Drug Facts

Product Profile

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

azithromycin monohydrate 500 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-857
Product ID 54348-857_eb018961-75d1-2d69-e053-2995a90a38be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065225
Listing Expiration 2026-12-31
Marketing Start 2019-07-10

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348857
Hyphenated Format 54348-857

Supplemental Identifiers

RxCUI
248656
UNII
JTE4MNN1MD

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 monohydrate (source: ndc)
Application Number ANDA065225 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-857-00) / 1 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-857-01) / 1 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-857-02) / 2 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

54348-857-00 1 BOTTLE in 1 BOX (54348-857-00) / 1 TABLET, FILM COATED in 1 BOTTLE 54348-857-01 1 BOTTLE in 1 BOX (54348-857-01) / 1 TABLET, FILM COATED in 1 BOTTLE 54348-857-02 1 BOTTLE in 1 BOX (54348-857-02) / 2 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

azithromycin monohydrate (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": "eb018961-75d1-2d69-e053-2995a90a38be", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["248656"], "spl_set_id": ["ba57ff26-cd02-4f57-ac92-b613d245a4ea"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-00)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-00", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-01)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-01", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-857-02)  / 2 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-857-02", "marketing_start_date": "20190710"}], "brand_name": "Azithromycin", "product_id": "54348-857_eb018961-75d1-2d69-e053-2995a90a38be", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "54348-857", "generic_name": "AZITHROMYCIN MONOHYDRATE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065225", "marketing_category": "ANDA", "marketing_start_date": "20190710", "listing_expiration_date": "20261231"}