Novolin
- Product NDC
- 0169-1833
- 11-digit product format
- 001691833
- Labeler code
- 0169
- Product ID
- 0169-1833_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Human Insulin
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA019938
- Marketing category
- BLA
- Marketing start
- 1991-06-25
- 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
- Novolin
- Brand name suffix
- R
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN HUMAN | 100 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Y17CTI5SR |
| Rxcui | 311033, 311034, 2206090, 2206092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-1833-02 | NovolinR | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 19 |
| 0169-1833-02 | NovolinR | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
| 0169-1833-11 | NovolinR | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 19 |
| 0169-1833-11 | NovolinR | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INSULIN HUMAN | ACTIVE INGREDIENT | 1Y17CTI5SR | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| INSULIN HUMAN | ACTIVE MOIETY | 1Y17CTI5SR | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| ZINC CHLORIDE | INACTIVE INGREDIENT | 86Q357L16B | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 12 | |
| INSULIN HUMAN | ACTIVE INGREDIENT | 1Y17CTI5SR | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| INSULIN HUMAN | ACTIVE MOIETY | 1Y17CTI5SR | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| ZINC CHLORIDE | INACTIVE INGREDIENT | 86Q357L16B | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-1833 | NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK] | 19 | Current NDC, Legacy NDC, 4 package rows | 20221208_aee7f1f3-612c-4027-8ce9-4fd1f41eed71.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2206090 | insulin regular, human 100 UNT/1 mL in 3 mL Pen Injector | PSN | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206092 | NovoLIN R 100 UNT/mL in 3 mL Pen Injector | PSN | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311033 | NovoLIN R 100 UNT/ML Injectable Solution | PSN | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311034 | regular insulin, human 100 UNT/ML Injectable Solution | PSN | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206092 | 3 ML insulin, regular, human 100 UNT/ML Pen Injector [Novolin R] | SBD | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311033 | insulin, regular, human 100 UNT/ML Injectable Solution [Novolin R] | SBD | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206090 | 3 ML insulin, regular, human 100 UNT/ML Pen Injector | SCD | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311034 | insulin, regular, human 100 UNT/ML Injectable Solution | SCD | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206092 | 3 ML Novolin R 100 UNT/ML Pen Injector | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206090 | insulin regular, human 100 UNT/1 ML per 3 ML Pen Injector | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311034 | insulin, human regular 100 UNT/ML Injectable Solution | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311033 | Novolin R 100 UNT/ML Injectable Solution | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206092 | Novolin R 100 UNT/ML per 3 ML Pen Injector | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 2206092 | Relion Novolin R 100 UNT/ML per 3 ML Pen Injector | SY | aee7f1f3-612c-4027-8ce9-4fd1f41eed71 | 19 |
| 311033 | NovoLIN R 100 UNT/ML Injectable Solution | PSN | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
| 311034 | regular insulin, human 100 UNT/ML Injectable Solution | PSN | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
| 311033 | insulin, regular, human 100 UNT/ML Injectable Solution [Novolin R] | SBD | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
| 311034 | insulin, regular, human 100 UNT/ML Injectable Solution | SCD | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
| 311034 | insulin, human regular 100 UNT/ML Injectable Solution | SY | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
| 311033 | Novolin R 100 UNT/ML Injectable Solution | SY | 78dadbee-c3b6-4d62-a338-731b24cc7ef0 | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-1833-02 | 00169183302 | 1 VIAL in 1 CARTON (0169-1833-02) / 10 mL in 1 VIAL | 1 vial | 1991-06-25 | 0000-00-00 | No | No | Current |
| 0169-1833-11 | 00169183311 | 1 VIAL in 1 CARTON (0169-1833-11) / 10 mL in 1 VIAL | 1 vial | 1991-06-25 | 0000-00-00 | No | No | Current |