azithromycin

Generic: azithromycin

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

Drug Facts

Product Profile

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

azithromycin dihydrate 200 mg/5mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1459
Product ID 70710-1459_6cf603d4-b79b-4a0a-906c-f1967a0db9a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211147
Listing Expiration 2026-12-31
Marketing Start 2018-08-06

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101459
Hyphenated Format 70710-1459

Supplemental Identifiers

RxCUI
141963 308459
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 (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA211147 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70710-1459-2) / 22.5 mL in 1 BOTTLE
source: ndc

Packages (1)

70710-1459-2 1 BOTTLE in 1 CARTON (70710-1459-2) / 22.5 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (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": "6cf603d4-b79b-4a0a-906c-f1967a0db9a4", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963", "308459"], "spl_set_id": ["99e5bd22-a721-4e2e-a46c-d61a53c25c3d"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70710-1459-2)  / 22.5 mL in 1 BOTTLE", "package_ndc": "70710-1459-2", "marketing_start_date": "20180806"}], "brand_name": "Azithromycin", "product_id": "70710-1459_6cf603d4-b79b-4a0a-906c-f1967a0db9a4", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70710-1459", "generic_name": "Azithromycin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA211147", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}