azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler slate run pharmaceuticals, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 200 mg/5mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-221
Product ID 70436-221_32f66ed6-7a90-559b-e063-6394a90aaf93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217036
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436221
Hyphenated Format 70436-221

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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA217036 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70436-221-34) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70436-221-34 1 BOTTLE in 1 CARTON (70436-221-34) / 15 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (200 mg/5mL)

Linked Drug Pages (1)

azithromycin dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32f66ed6-7a90-559b-e063-6394a90aaf93", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963", "308459"], "spl_set_id": ["33d4ac05-b564-440c-971d-b78590dd2c32"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70436-221-34)  / 15 mL in 1 BOTTLE", "package_ndc": "70436-221-34", "marketing_start_date": "20240101"}], "brand_name": "azithromycin dihydrate", "product_id": "70436-221_32f66ed6-7a90-559b-e063-6394a90aaf93", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70436-221", "generic_name": "azithromycin dihydrate", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA217036", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}