azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-445
Product ID 72789-445_47a9d9a0-55c6-0d22-e063-6394a90a1518
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
Listing Expiration 2027-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789445
Hyphenated Format 72789-445

Supplemental Identifiers

RxCUI
248656
UPC
0372789445076
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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA208249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-02)
  • 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-07)
  • 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-79)
source: ndc

Packages (3)

72789-445-02 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-02) 72789-445-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-07) 72789-445-79 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-79)

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": "47a9d9a0-55c6-0d22-e063-6394a90a1518", "openfda": {"upc": ["0372789445076"], "unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["0c926669-62b2-4ad3-8289-173c5818a9c1"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-02)", "package_ndc": "72789-445-02", "marketing_start_date": "20241104"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-07)", "package_ndc": "72789-445-07", "marketing_start_date": "20241022"}, {"sample": false, "description": "1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-79)", "package_ndc": "72789-445-79", "marketing_start_date": "20241210"}], "brand_name": "Azithromycin Dihydrate", "product_id": "72789-445_47a9d9a0-55c6-0d22-e063-6394a90a1518", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "72789-445", "generic_name": "Azithromycin dihydrate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA208249", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20271231"}