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
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
85551-123-308555101233030 mL in 1 VIAL, GLASS (85551-123-30)30 ml2026-06-010Current