NDC 0002-8501

Humulin R U-500

Insulin Human

Humulin R U-500 is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Insulin Human.

Product ID0002-8501_01dcc798-7fba-4eb7-af12-001ab92dee6e
NDC0002-8501
Product TypeHuman Prescription Drug
Proprietary NameHumulin R U-500
Generic NameInsulin Human
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1994-03-31
Marketing CategoryNDA / NDA
Application NumberNDA018780
Labeler NameEli Lilly and Company
Substance NameINSULIN HUMAN
Active Ingredient Strength500 [iU]/mL
Pharm ClassesInsulin [EPC],Insulin [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0002-8501-01

1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) > 20 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date1997-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-8501-01 [00002850101]

Humulin R U-500 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA018780
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-01-06

Drug Details

Active Ingredients

IngredientStrength
INSULIN HUMAN500 [iU]/mL

OpenFDA Data

SPL SET ID:b60e8dd0-1d48-4dc9-87fd-e14675255e8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 249220
  • 1731317
  • 1731315
  • 351859
  • UPC Code
  • 0300028824276
  • Pharmacological Class

    • Insulin [EPC]
    • Insulin [CS]

    NDC Crossover Matching brand name "Humulin R U-500" or generic name "Insulin Human"

    NDCBrand NameGeneric Name
    47918-874AfrezzaInsulin Human
    0002-8215HumulinInsulin human
    0002-8315HumulinInsulin human
    0002-8501HumulinInsulin human
    0002-8715HumulinInsulin human
    0002-8803HumulinInsulin human
    0002-8805HumulinInsulin human
    0002-8824HumulinInsulin human
    0338-0126MYXREDLINinsulin human

    Trademark Results [Humulin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HUMULIN
    HUMULIN
    75773392 2345798 Live/Registered
    Eli Lilly and Company
    1999-08-11
    HUMULIN
    HUMULIN
    75253619 not registered Dead/Abandoned
    Eli Lilly and Company
    1997-03-07
    HUMULIN
    HUMULIN
    73303147 1201754 Live/Registered
    Eli Lilly and Company
    1981-03-27

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