azithromycin

Generic: azithromycin

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler epic pharma, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 100 mg/5mL

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-147
Product ID 42806-147_8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207531
Listing Expiration 2027-12-31
Marketing Start 2018-04-10

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806147
Hyphenated Format 42806-147

Supplemental Identifiers

RxCUI
141963 308459
UNII
JTE4MNN1MD

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 ANDA207531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE, PLASTIC (42806-147-31)
source: ndc

Packages (1)

42806-147-31 15 mL in 1 BOTTLE, PLASTIC (42806-147-31)

Ingredients (1)

azithromycin monohydrate (100 mg/5mL)

Linked Drug Pages (1)

AZITHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["141963", "308459"], "spl_set_id": ["59c4b783-4ff7-4269-969b-58a10e12b12b"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (42806-147-31)", "package_ndc": "42806-147-31", "marketing_start_date": "20180410"}], "brand_name": "AZITHROMYCIN", "product_id": "42806-147_8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "42806-147", "generic_name": "azithromycin", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZITHROMYCIN", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "100 mg/5mL"}], "application_number": "ANDA207531", "marketing_category": "ANDA", "marketing_start_date": "20180410", "listing_expiration_date": "20271231"}