Humulin
- Product NDC
- 50090-0352
- 11-digit product format
- 500900352
- Labeler code
- 50090
- Product ID
- 50090-0352_270de939-e175-41d2-ab62-6409f586bc38
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Insulin human
- Dosage form
- INJECTION, SUSPENSION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- NDA018781
- Marketing category
- NDA
- Marketing start
- 1983-06-27
- Marketing end
- 0000-00-00
- Substance
- INSULIN HUMAN
- Active strength
- 100 [iU]/mL
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1997359-a049-4781-b04b-084a7f3cb039 | Product name | 2 | 20200325 |
| aa12d3c0-d2b4-4c50-9af0-cb08b230ec20 | Product name | 2 | 20200323 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-0352-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8d91-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use HUMULIN N safely and effectively. See full prescribing information for HUMULIN N. HUMULIN ® N (human insulin [rDNA origin] isophane suspension), injectable suspension, for subcutaneous use Initial U.S. Approval: 1982 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0352-0 | Humulin N | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | 12 | |
| 50090-0352-9 | Humulin N | 10 mL in 1 VIAL | INJECTION, SUSPENSION | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0352-0 | ML - Milliliter | 50090-0352 | 8eb09164-6d89-4197-9003-88e7b17a5943 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0352 | HUMULIN N (INSULIN HUMAN) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] | 12 | Legacy NDC, 2 package rows | 20171021_456e226e-e7b0-4850-b649-3d9e5533893c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311026 | HumuLIN N 100 UNT/ML Injectable Suspension | PSN | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
| 311028 | insulin isophane (NPH), human 100 UNT/mL Injectable Suspension | PSN | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
| 311026 | insulin isophane, human 100 UNT/ML Injectable Suspension [Humulin N] | SBD | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
| 311028 | insulin isophane, human 100 UNT/ML Injectable Suspension | SCD | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
| 311026 | Humulin N 100 UNT/ML Injectable Suspension | SY | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
| 311028 | insulin isophane (NPH), human 100 UNT/ML Injectable Suspension | SY | 456e226e-e7b0-4850-b649-3d9e5533893c | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 50090-0352-0 | 50090035200 | 1 in 1 CARTON | Historical | |
| 50090-0352-9 | 50090035209 | 10 mL in 1 VIAL | 10 ml | Historical |