azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-153
Product ID 82804-153_edecf20d-c681-418b-9c47-02fb32d2b3c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
Listing Expiration 2026-12-31
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 82804153
Hyphenated Format 82804-153

Supplemental Identifiers

RxCUI
248656
UPC
0382804153046
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
  • 4 TABLET, FILM COATED in 1 BOTTLE (82804-153-04)
source: ndc

Packages (1)

82804-153-04 4 TABLET, FILM COATED in 1 BOTTLE (82804-153-04)

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": "edecf20d-c681-418b-9c47-02fb32d2b3c0", "openfda": {"upc": ["0382804153046"], "unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["edecf20d-c681-418b-9c47-02fb32d2b3c0"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (82804-153-04)", "package_ndc": "82804-153-04", "marketing_start_date": "20240925"}], "brand_name": "Azithromycin Dihydrate", "product_id": "82804-153_edecf20d-c681-418b-9c47-02fb32d2b3c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "82804-153", "generic_name": "Azithromycin dihydrate", "labeler_name": "Proficient Rx LP", "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": "20261231"}