azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler precision dose, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 600 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-690
Product ID 68094-690_5d373887-5ca3-4911-bd76-0ff51141df5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207566
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 68094690
Hyphenated Format 68094-690

Supplemental Identifiers

RxCUI
204844
UPC
0368094690300
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 ANDA207566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68094-690-30)
source: ndc

Packages (1)

68094-690-30 30 TABLET, FILM COATED in 1 BOTTLE (68094-690-30)

Ingredients (1)

azithromycin dihydrate (600 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": "5d373887-5ca3-4911-bd76-0ff51141df5f", "openfda": {"upc": ["0368094690300"], "unii": ["5FD1131I7S"], "rxcui": ["204844"], "spl_set_id": ["b88f5839-8e8b-4bf6-a577-5c8b7cffeec6"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68094-690-30)", "package_ndc": "68094-690-30", "marketing_start_date": "20240215"}], "brand_name": "Azithromycin Dihydrate", "product_id": "68094-690_5d373887-5ca3-4911-bd76-0ff51141df5f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68094-690", "generic_name": "Azithromycin dihydrate", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "600 mg/1"}], "application_number": "ANDA207566", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}