azithromycin

Generic: azithromycin

Labeler: state health services, texas department of
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler state health services, texas department of
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 200 mg/5mL

Manufacturer
STATE HEALTH SERVICES, TEXAS DEPARTMENT OF

Identifiers & Regulatory

Product NDC 55695-003
Product ID 55695-003_1287e725-48d5-e23e-e063-6394a90a96ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065246
Listing Expiration 2026-12-31
Marketing Start 2010-12-17

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55695003
Hyphenated Format 55695-003

Supplemental Identifiers

RxCUI
141963 308459
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 (source: ndc)
Application Number ANDA065246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (55695-003-00)
  • 15 mL in 1 BOTTLE (55695-003-01)
source: ndc

Packages (2)

55695-003-00 30 mL in 1 BOTTLE (55695-003-00) 55695-003-01 15 mL in 1 BOTTLE (55695-003-01)

Ingredients (1)

azithromycin monohydrate (200 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": "1287e725-48d5-e23e-e063-6394a90a96ac", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["141963", "308459"], "spl_set_id": ["2b821631-0df2-0fb2-e054-00144ff8d46c"], "manufacturer_name": ["STATE HEALTH SERVICES, TEXAS DEPARTMENT OF"]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (55695-003-00)", "package_ndc": "55695-003-00", "marketing_start_date": "20101228"}, {"sample": false, "description": "15 mL in 1 BOTTLE (55695-003-01)", "package_ndc": "55695-003-01", "marketing_start_date": "20101228"}], "brand_name": "Azithromycin", "product_id": "55695-003_1287e725-48d5-e23e-e063-6394a90a96ac", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "55695-003", "generic_name": "Azithromycin", "labeler_name": "STATE HEALTH SERVICES, TEXAS DEPARTMENT OF", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA065246", "marketing_category": "ANDA", "marketing_start_date": "20101217", "listing_expiration_date": "20261231"}