Novolin
- Product NDC
- 0169-3007
- 11-digit product format
- 001693007
- Labeler code
- 0169
- Product ID
- 0169-3007_c7164ea1-aa3e-4359-a3f0-a34c78e78398
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Human Insulin
- Dosage form
- INJECTION, SUSPENSION
- Route
- SUBCUTANEOUS
- Labeler
- Novo Nordisk
- Application
- BLA019991
- Marketing category
- BLA
- Marketing start
- 2018-06-01
- 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
- 70/30
- 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 | 213442, 311048, 847187, 2049380 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-3007-01 | Novolin70/30 | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SUSPENSION | 3 | | 18 |
| 0169-3007-12 | Novolin70/30 | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SUSPENSION | 3 | | 18 |
| 0169-3007-15 | Novolin70/30 | 5 in 1 CARTON | INJECTION, SUSPENSION | 5 | | 18 |
| 0169-3007-25 | Novolin70/30 | 5 in 1 CARTON | INJECTION, SUSPENSION | 5 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| INSULIN HUMAN | ACTIVE INGREDIENT | 1Y17CTI5SR | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| INSULIN HUMAN | ACTIVE MOIETY | 1Y17CTI5SR | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| PROTAMINE SULFATE | INACTIVE INGREDIENT | 0DE9724IHC | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
| ZINC CHLORIDE | INACTIVE INGREDIENT | 86Q357L16B | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-3007 | NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK] | 18 | Current NDC, Legacy NDC, 4 package rows | 20221208_508a2763-3cb7-4be5-9e53-544e84cd9b1f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 847187 | insulin isophane, human 70 UNT/ML / insulin, human UNT/ML in 3 ML Pen Injector | PSN | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 311048 | insulin, human isophane / insulin regular 70/30 Injectable Suspension | PSN | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 2049380 | NovoLIN 70/30 in 3 ML Pen Injector | PSN | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 213442 | NovoLIN 70/30 Injectable Suspension | PSN | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 2049380 | 3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector [Novolin] | SBD | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 213442 | insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin] | SBD | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 847187 | 3 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector | SCD | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 311048 | insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension | SCD | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 847187 | insulin isophane, human 70 UNT/ML / insulin, human UNT/ML per 3 ML Pen Injector | SY | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 311048 | insulin, human mixed 70/30 100 UNT/ML Injectable Suspension | SY | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 213442 | Novolin 70/30 Injectable Suspension | SY | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 2049380 | Novolin 70/30 per 3 ML Pen Injector | SY | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
| 213442 | Relion Novolin 70/30 Injectable Suspension | SY | 508a2763-3cb7-4be5-9e53-544e84cd9b1f | 18 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-3007-01 | 00169300701 | 3 mL in 1 SYRINGE, PLASTIC | 3 ml | | | | | Historical |
| 0169-3007-12 | 00169300712 | 3 mL in 1 SYRINGE, PLASTIC | 3 ml | | | | | Historical |
| 0169-3007-15 | 00169300715 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-3007-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3007-01) | | 2018-06-01 | 0000-00-00 | No | No | Current |
| 0169-3007-25 | 00169300725 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-3007-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3007-12) | | 2018-06-01 | 0000-00-00 | No | No | Current |