zithromax

Generic: azithromycin dihydrate

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zithromax
Generic Name azithromycin dihydrate
Labeler pfizer laboratories div pfizer inc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 200 mg/5mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-3140
Product ID 0069-3140_e15f2173-8700-4392-96a4-8560772b6f8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050710
Listing Expiration 2027-12-31
Marketing Start 1995-10-19

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00693140
Hyphenated Format 0069-3140

Supplemental Identifiers

RxCUI
105260 141963 211307 212446 226827 248656 308459 308460 749780 749783 750149 750157
UPC
0300693060306 0300693070305
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 zithromax (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number NDA050710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0069-3140-19 1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (200 mg/5mL)

Linked Drug Pages (1)

Zithromax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e15f2173-8700-4392-96a4-8560772b6f8a", "openfda": {"upc": ["0300693060306", "0300693070305"], "unii": ["5FD1131I7S"], "rxcui": ["105260", "141963", "211307", "212446", "226827", "248656", "308459", "308460", "749780", "749783", "750149", "750157"], "spl_set_id": ["db52b91e-79f7-4cc1-9564-f2eee8e31c45"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0069-3140-19)  / 30 mL in 1 BOTTLE", "package_ndc": "0069-3140-19", "marketing_start_date": "19951019"}], "brand_name": "Zithromax", "product_id": "0069-3140_e15f2173-8700-4392-96a4-8560772b6f8a", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "0069-3140", "generic_name": "azithromycin dihydrate", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zithromax", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "200 mg/5mL"}], "application_number": "NDA050710", "marketing_category": "NDA", "marketing_start_date": "19951019", "listing_expiration_date": "20271231"}