azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: aci healthcare usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler aci healthcare usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
ACI Healthcare USA, Inc.

Identifiers & Regulatory

Product NDC 71093-175
Product ID 71093-175_77a7e874-29c3-449c-92b3-448023e67197
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215773
Listing Expiration 2026-12-31
Marketing Start 2023-07-30

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71093175
Hyphenated Format 71093-175

Supplemental Identifiers

RxCUI
248656
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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA215773 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71093-175-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71093-175-05)
source: ndc

Packages (2)

71093-175-01 30 TABLET, FILM COATED in 1 BOTTLE (71093-175-01) 71093-175-05 500 TABLET, FILM COATED in 1 BOTTLE (71093-175-05)

Ingredients (1)

azithromycin dihydrate (500 mg/1)

Linked Drug Pages (1)

Azithromycin Dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "77a7e874-29c3-449c-92b3-448023e67197", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["fb2f83a2-507b-4cf3-81ea-d10c46c0f8ea"], "manufacturer_name": ["ACI Healthcare USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71093-175-01)", "package_ndc": "71093-175-01", "marketing_start_date": "20230930"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71093-175-05)", "package_ndc": "71093-175-05", "marketing_start_date": "20230930"}], "brand_name": "Azithromycin Dihydrate", "product_id": "71093-175_77a7e874-29c3-449c-92b3-448023e67197", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "71093-175", "generic_name": "Azithromycin Dihydrate", "labeler_name": "ACI Healthcare USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA215773", "marketing_category": "ANDA", "marketing_start_date": "20230730", "listing_expiration_date": "20261231"}