azithromycin

Generic: azithromycin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler preferred pharmaceuticals inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 100 mg/5mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8675
Product ID 68788-8675_b24a545d-b889-455f-be44-e9d2b9215583
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065246
Listing Expiration 2027-12-31
Marketing Start 2024-05-23

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888675
Hyphenated Format 68788-8675

Supplemental Identifiers

RxCUI
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
  • 100 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (68788-8675-1)
source: ndc

Packages (1)

68788-8675-1 15 mL in 1 BOTTLE (68788-8675-1)

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": "b24a545d-b889-455f-be44-e9d2b9215583", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["308459"], "spl_set_id": ["ac327054-21ab-401c-a27a-48259db18f89"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (68788-8675-1)", "package_ndc": "68788-8675-1", "marketing_start_date": "20240523"}], "brand_name": "Azithromycin", "product_id": "68788-8675_b24a545d-b889-455f-be44-e9d2b9215583", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68788-8675", "generic_name": "Azithromycin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "100 mg/5mL"}], "application_number": "ANDA065246", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20271231"}