Home NDC 0002-8215-17 Humulin
Product NDC 0002-8215
Requested package NDC 0002-8215-17
11-digit product format 000028215
Labeler code 0002
Product ID 0002-8215_42527ae4-c593-4e13-8b77-c0511198c708
Type HUMAN OTC DRUG
Nonproprietary name Insulin human
Dosage form INJECTION, SOLUTION
Route PARENTERAL
Labeler Eli Lilly and Company
Application BLA018780
Marketing category BLA
Marketing start 1983-06-27
Substance INSULIN HUMAN
Active strength 100 [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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INSULIN HUMAN 100 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y17CTI5SR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311034 Internal RxNorm lookup 311036 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0002-8215-01 Humulin R 1 in 1 CARTON INJECTION, SOLUTION 1 34 0002-8215-01 Humulin R 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 34 0002-8215-17 Humulin R 3 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 3 34 0002-8215-17 Humulin R 1 in 1 CARTON INJECTION, SOLUTION 1 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded insulin human ACTIVE INGREDIENT 1Y17CTI5SR HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 insulin human ACTIVE MOIETY 1Y17CTI5SR HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 glycerin INACTIVE INGREDIENT PDC6A3C0OX HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 Metacresol INACTIVE INGREDIENT GGO4Y809LO HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 Water INACTIVE INGREDIENT 059QF0KO0R HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY
] 22 insulin human ACTIVE INGREDIENT 1Y17CTI5SR HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 insulin human ACTIVE MOIETY 1Y17CTI5SR HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 Hydrochloric acid INACTIVE INGREDIENT QTT17582CB HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 Metacresol INACTIVE INGREDIENT GGO4Y809LO HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 Sodium hydroxide INACTIVE INGREDIENT 55X04QC32I HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0002-8215 HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [ELI LILLY AND COMPANY] 33 Current NDC, Legacy NDC, 4 package rows 20230913_b519bd83-038c-4ec5-a231-a51ec5cc291f.zip
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 · 3 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 018780 Humulin R U-100 insulin human 351(a) OTC 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 311036 HumuLIN R 100 UNT/ML Injectable Solution PSN b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311034 regular insulin, human 100 UNT/ML Injectable Solution PSN b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311036 insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R] SBD b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311034 insulin, regular, human 100 UNT/ML Injectable Solution SCD b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311036 Humulin R 100 UNT/ML Injectable Solution SY b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311034 insulin, human regular 100 UNT/ML Injectable Solution SY b519bd83-038c-4ec5-a231-a51ec5cc291f 34 311036 HumuLIN R 100 UNT/ML Injectable Solution PSN 81199e55-ade9-46de-a5a3-c0415acee403 25 311034 regular insulin, human 100 UNT/ML Injectable Solution PSN 81199e55-ade9-46de-a5a3-c0415acee403 25 311036 insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R] SBD 81199e55-ade9-46de-a5a3-c0415acee403 25 311034 insulin, regular, human 100 UNT/ML Injectable Solution SCD 81199e55-ade9-46de-a5a3-c0415acee403 25 311036 Humulin R 100 UNT/ML Injectable Solution SY 81199e55-ade9-46de-a5a3-c0415acee403 25 311034 insulin, human regular 100 UNT/ML Injectable Solution SY 81199e55-ade9-46de-a5a3-c0415acee403 25 311036 HumuLIN R 100 UNT/ML Injectable Solution PSN 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2 311034 regular insulin, human 100 UNT/ML Injectable Solution PSN 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2 311036 insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R] SBD 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2 311034 insulin, regular, human 100 UNT/ML Injectable Solution SCD 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2 311036 Humulin R 100 UNT/ML Injectable Solution SY 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2 311034 insulin, human regular 100 UNT/ML Injectable Solution SY 9ec3e28a-cea9-4e45-9057-e5bf8e37014c 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0002-8215-17 00002821517 1 VIAL, MULTI-DOSE in 1 CARTON (0002-8215-17) / 3 mL in 1 VIAL, MULTI-DOSE 2009-12-04 2026-08-11 No No Current