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NDC 00955-3900-03 Insulin glargine U-300 300 [iU]/mL Details
Insulin glargine U-300 300 [iU]/mL
Insulin glargine U-300 is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Winthrop U.S, a business of sanofi-aventis U.S. LLC. The primary component is INSULIN GLARGINE.
Product Information
| NDC | 00955-3900 |
|---|---|
| Product ID | 0955-3900_0bef2944-7ab5-e6bf-e063-6394a90af56a |
| Associated GPIs | |
| GCN Sequence Number | 073567 |
| GCN Sequence Number Description | insulin glargine,hum.rec.anlog INSULN PEN 300/ML SUBCUT |
| HIC3 | C4G |
| HIC3 Description | INSULINS |
| GCN | 37988 |
| HICL Sequence Number | 022025 |
| HICL Sequence Number Description | INSULIN GLARGINE,HUMAN RECOMBINANT ANALOG |
| Brand/Generic | Generic |
| Proprietary Name | Insulin glargine U-300 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | insulin glargine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | [iU]/mL |
| Substance Name | INSULIN GLARGINE |
| Labeler Name | Winthrop U.S, a business of sanofi-aventis U.S. LLC |
| Pharmaceutical Class | Insulin Analog [EPC], Insulin [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA206538 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00955-3900-03 (00955390003)
| NDC Package Code | 0955-3900-03 |
|---|---|
| Billing NDC | 00955390003 |
| Package | 3 SYRINGE in 1 CARTON (0955-3900-03) / 1.5 mL in 1 SYRINGE (0955-3900-01) |
| Marketing Start Date | 2023-01-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |