Humatin

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Humatin
Generic name: PAROMOMYCIN SULFATE
Manufacturer: Waylis Therapeutics LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: a725f022-ec3c-430d-8021-96c861b9893c
SPL ID: 4b33337a-4e4b-42f3-923f-5b61f02fc463
Version: 3
Effective date: 2025-11-13
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:28

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	065173	derived:openfda.application_number
application number		ANDA065173	openfda.application_number
brand name		Humatin	openfda.brand_name
generic name		PAROMOMYCIN SULFATE	openfda.generic_name
manufacturer name		Waylis Therapeutics LLC	openfda.manufacturer_name
ndc	package	80725-250-01	openfda.package_ndc
ndc	product	80725-250	openfda.product_ndc
ndc11	package	80725025001	derived:openfda.package_ndc
rxcui		314184	openfda.rxcui
rxcui		207347	openfda.rxcui
spl id		4b33337a-4e4b-42f3-923f-5b61f02fc463	id
spl set id		a725f022-ec3c-430d-8021-96c861b9893c	set_id
unii		845NU6GJPS	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily. To report SUSPECTED ADVERSE REACTIONS, Waylis Therapeutics LLC at 844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.