Humulin
- Product NDC
- 0002-8501
- 11-digit product format
- 000028501
- Labeler code
- 0002
- Product ID
- 0002-8501_7872727a-5d70-410a-ad64-b3b47afceb5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Insulin human
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Eli Lilly and Company
- Application
- BLA018780
- Marketing category
- BLA
- Marketing start
- 1994-03-31
- Substance
- INSULIN HUMAN
- Active strength
- 500 [iU]/mL
- Pharmacologic classes
- Insulin [CS], Insulin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Humulin
- Brand name suffix
- R U-500
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN HUMAN | 500 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Y17CTI5SR |
| Rxcui | 249220, 351859, 1731315, 1731317 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0002-8501-01 | HumulinR U-500 | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 40 |
| 0002-8501-01 | HumulinR U-500 | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 40 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Insulin human | ACTIVE INGREDIENT | 1Y17CTI5SR | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Insulin human | ACTIVE MOIETY | 1Y17CTI5SR | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Metacresol | INACTIVE INGREDIENT | GGO4Y809LO | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
| Zinc | INACTIVE INGREDIENT | J41CSQ7QDS | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0002-8501 | HUMULIN R U-500 (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R U-500 KWIKPEN (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY] | 40 | Current NDC, Legacy NDC, 2 package rows | 20240402_b60e8dd0-1d48-4dc9-87fd-e14675255e8c.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1731317 | HumuLIN R (concentrated) 500 UNT/ML in 3 ML Pen Injector | PSN | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 351859 | HumuLIN R (concentrated) 500 UNT/ML Injectable Solution | PSN | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 1731315 | regular insulin, human (concentrated) 500 UNT/ML in 3 ML Pen Injector | PSN | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 249220 | regular insulin, human (concentrated) 500 UNT/ML Injectable Solution | PSN | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 1731317 | 3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R] | SBD | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 351859 | insulin, regular, human 500 UNT/ML Injectable Solution [Humulin R] | SBD | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 1731315 | 3 ML insulin, regular, human 500 UNT/ML Pen Injector | SCD | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 249220 | insulin, regular, human 500 UNT/ML Injectable Solution | SCD | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 1731317 | 3 ML Humulin R 500 UNT/ML Pen Injector | SY | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 351859 | Humulin R 500 UNT/ML Injectable Solution | SY | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
| 249220 | insulin, human regular 500 UNT/ML Injectable Solution | SY | b60e8dd0-1d48-4dc9-87fd-e14675255e8c | 40 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0002-8501-01 | 00002850101 | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8501-01) / 20 mL in 1 VIAL, MULTI-DOSE | 1997-01-06 | 0000-00-00 | No | No | Current |