humatin

Generic: paromomycin sulfate

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name humatin
Generic Name paromomycin sulfate
Labeler waylis therapeutics llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

paromomycin sulfate 250 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-250
Product ID 80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065173
Listing Expiration 2026-12-31
Marketing Start 2021-04-08

Pharmacologic Class

Classes
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725250
Hyphenated Format 80725-250

Supplemental Identifiers

RxCUI
207347 314184
UPC
0380725250011
UNII
845NU6GJPS

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 humatin (source: ndc)
Generic Name paromomycin sulfate (source: ndc)
Application Number ANDA065173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (80725-250-01)
source: ndc

Packages (1)

80725-250-01 100 CAPSULE in 1 BOTTLE (80725-250-01)

Ingredients (1)

paromomycin sulfate (250 mg/1)

Linked Drug Pages (1)

Humatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b33337a-4e4b-42f3-923f-5b61f02fc463", "openfda": {"upc": ["0380725250011"], "unii": ["845NU6GJPS"], "rxcui": ["207347", "314184"], "spl_set_id": ["a725f022-ec3c-430d-8021-96c861b9893c"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (80725-250-01)", "package_ndc": "80725-250-01", "marketing_start_date": "20210408"}], "brand_name": "Humatin", "product_id": "80725-250_4b33337a-4e4b-42f3-923f-5b61f02fc463", "dosage_form": "CAPSULE", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "80725-250", "generic_name": "PAROMOMYCIN SULFATE", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Humatin", "active_ingredients": [{"name": "PAROMOMYCIN SULFATE", "strength": "250 mg/1"}], "application_number": "ANDA065173", "marketing_category": "ANDA", "marketing_start_date": "20210408", "listing_expiration_date": "20261231"}