Regular Insulin, Human Injectable Solution
- Brand(s)
- Humulin R, Novolin R
- Category(s)
- otc, prescription
- SPL Type(s)
- Human OTC, Human Prescription
- Master SPL
- Eli Lilly And Company (2014-09-23)
- Oldest Current Product
- 1991-06-25
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\REGULAR INSULIN, HUMAN
- FDAOB
- INJECTION\INJECTION\INSULIN RECOMBINANT HUMAN\rdfq
- SPL Active
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN HUMAN
- SPL Moiety
- SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN HUMAN
product(s) by strength(s)
regular insulin, human 100 unt/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001691833 | Novolin R | NDA | Novo Nordisk | 1991-06-25 | INSULIN HUMAN | SUBCUTANEOUS | INJECTION, SOLUTION | NDA019938 | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548683619 | Humulin R | NDA | Physicians Total Care, Inc. | 1995-07-27 | INSULIN HUMAN | SUBCUTANEOUS | INJECTION, SOLUTION | 000028215 | NDA018780 | 9ec3e28a-cea9-4e45-9057-e5bf8e37014c |
| 2 | 647251833 | Novolin R | NDA | Tya Pharmaceuticals | 1991-06-25 | INSULIN HUMAN | SUBCUTANEOUS | INJECTION, SOLUTION | 001691833 | NDA019938 | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 |
regular insulin, human 500 unt/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000028501 | Humulin R | NDA | Eli Lilly And Company | 1997-01-06 | INSULIN HUMAN | SUBCUTANEOUS | INJECTION, SOLUTION | NDA018780 | b60e8dd0-1d48-4dc9-87fd-e14675255e8c |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA018780 | HUMULIN R | ELI LILLY AND CO | 1982-10-28 | NDA018780_001, NDA018780_004, NDA018780_005 | |
| 2 | NDA019529 | HUMULIN BR | True | ELI LILLY AND CO | 1986-04-28 | NDA019529_001 |
| 3 | NDA019938 | NOVOLIN R | NOVO NORDISK INC | 1991-06-25 | NDA019938_001 | |
| 4 | NDA021028 | VELOSULIN BR | True | NOVO NORDISK INC | 1999-07-19 | NDA021028_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA018780_001 | OTC | INSULIN RECOMBINANT HUMAN (100 UNITS/ML) | INJECTION | True | 1982-10-28 | HUMULIN R |
| 2 | NDA018780_004 | RX | INSULIN RECOMBINANT HUMAN (500 UNITS/ML) | INJECTION | True | 1994-03-31 | HUMULIN R |
| 3 | NDA018780_005 | OTC | INSULIN RECOMBINANT HUMAN (100 UNITS/ML) | INJECTION | True | 1998-08-06 | HUMULIN R |
| 4 | NDA019529_001 | discontinued | INSULIN RECOMBINANT HUMAN (100 UNITS/ML) | INJECTION | False | 1986-04-28 | HUMULIN BR |
| 5 | NDA019938_001 | OTC | INSULIN RECOMBINANT HUMAN (100 UNITS/ML) | INJECTION | True | 1991-06-25 | NOVOLIN R |
| 6 | NDA021028_001 | discontinued | INSULIN RECOMBINANT HUMAN (100 UNITS/ML) | INJECTION | False | 1999-07-19 | VELOSULIN BR |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 (view SPL) | These highlights do not include all the information needed to use Novolin R safely and effectively. See full prescribing information for Novolin R. Initial U.S. Approval: 1991 Novolin R (Regular, Human Insulin [rDNA origin] USP) solution for subcutaneous or intravenous use | otc | Human OTC | Tya Pharmaceuticals | RELABEL, REPACK | 2013-03-09 | 2 | 647251833 |
| 2 | 9ec3e28a-cea9-4e45-9057-e5bf8e37014c (view SPL) | HUMULIN R REGULAR INSULIN HUMAN INJECTION, USP(rDNA ORIGIN)100 UNITS PER ML (U-100) | otc | Human OTC | Physicians Total Care, Inc. | relabel | 2010-11-08 | 2 | 548683619 |
| 3 | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 (view SPL) | These highlights do not include all the information needed to use Novolin R safely and effectively. See full prescribing information for Novolin R. Novolin R (Regular, Human Insulin [rDNA origin] USP) solution for subcutaneous or intravenous use Initial U.S. Approval: 1991 | otc | Human OTC | Novo Nordisk | API MANUFACTURE, MANUFACTURE | 2013-03-09 | 12 | 001691833 |
| 4 | b519bd83-038c-4ec5-a231-a51ec5cc291f (view SPL) | INFORMATION FOR THE PHYSICIANHUMULIN R REGULAR INSULIN HUMAN INJECTION, USP (rDNA ORIGIN) 100 UNITS PER ML (U-100) | otc | Human OTC | Eli Lilly And Company | 2015-06-30 | 22 | 000028215 | |
| 5 | b60e8dd0-1d48-4dc9-87fd-e14675255e8c (view SPL) | INFORMATION FOR THE PHYSICIANHUMULIN RREGULARU-500 (CONCENTRATED)INSULIN HUMAN INJECTION, USP(rDNA ORIGIN) | prescription | Human Prescription | Eli Lilly And Company | 2014-09-23 | 15 | 000028501 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII