azithromycin

Generic: azithromycin

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler zydus lifesciences limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 100 mg/5mL

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1422
Product ID 70771-1422_654b77ea-07ad-4747-ac35-5a2eb41f4588
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 707711422
Hyphenated Format 70771-1422

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
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70771-1422-1) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70771-1422-1 1 BOTTLE in 1 CARTON (70771-1422-1) / 15 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (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": "654b77ea-07ad-4747-ac35-5a2eb41f4588", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963", "308459"], "spl_set_id": ["0b63649d-558c-4250-90ee-af6e1e5c6d2c"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70771-1422-1)  / 15 mL in 1 BOTTLE", "package_ndc": "70771-1422-1", "marketing_start_date": "20180806"}], "brand_name": "Azithromycin", "product_id": "70771-1422_654b77ea-07ad-4747-ac35-5a2eb41f4588", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70771-1422", "generic_name": "Azithromycin", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "100 mg/5mL"}], "application_number": "ANDA211147", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}