R-Gene

Product NDC
0009-0436
11-digit product format
000090436
Labeler code
0009
Product ID
0009-0436_92dc2b43-3599-4859-b08b-29c024171f08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arginine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA016931
Marketing category
NDA
Marketing start
1976-06-15
Substance
ARGININE HYDROCHLORIDE
Active strength
10 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
R-Gene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGININE HYDROCHLORIDE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF7LTH1E20Y

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0436-01R-Gene1 in 1 CARTONINJECTION, SOLUTION118
0009-0436-01R-Gene300 mL in 1 CONTAINERINJECTION, SOLUTION30018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0436-01ML - Milliliter0009-04367d39fd96-d043-4bbe-89b2-63ae71b2eea112013-03-03
0009-0436-24ML - Milliliter0009-04361f3a382d-ea60-4c2c-b2a1-35bcf5a874d512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0436R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]18Current NDC, Legacy NDC, 2 package rows20240403_6accf33f-9841-4327-8923-93c42020ef12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0436-01000090436011 CONTAINER in 1 CARTON (0009-0436-01) / 300 mL in 1 CONTAINER1 container1976-06-150000-00-00NoNoCurrent