Non-proprietary name

Product NDC
85551-123
11-digit product format
855510123
Labeler code
85551
Product ID
85551-123_522eebc2-ab9d-2e45-e063-6294a90a43fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
L- Arginine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Xseer Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-06-01
Substance
ARGININE HYDROCHLORIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Non-proprietary name
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGININE HYDROCHLORIDE100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F7LTH1E20YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c6c0ac6-0d2a-b865-e063-6294a90aa3d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-proprietary nameL- ARGININEXseer Pharmaceuticals3c6c0ac6-0d2a-b865-e063-6294a90aa3d22026-05-19WarningsExact identifier
ndc (product): 85551-123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85551-123-308555101233030 mL in 1 VIAL, GLASS (85551-123-30) 30 ml2026-06-01NoNoCurrent