INSULIN GLARGINE
- Product NDC
- 72572-422
- 11-digit product format
- 725720422
- Labeler code
- 72572
- Product ID
- 72572-422_83f8663d-cb21-9b78-e315-e0db15befb18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine-yfgn
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Civica, Inc.
- Application
- BLA761201
- Marketing category
- BLA
- Marketing start
- 2025-10-30
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INSULIN GLARGINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN GLARGINE | 100 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2ZM8CX04RZ |
| Rxcui | 2563971 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72572-422-01 | INSULIN GLARGINE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 72572-422-01 | INSULIN GLARGINE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 1 |
| 72572-422-05 | INSULIN GLARGINE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 1 |
| 72572-422-05 | INSULIN GLARGINE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72572-422-01 | 72572042201 | 1 SYRINGE in 1 CARTON (72572-422-01) / 3 mL in 1 SYRINGE | 1 syringe | 2025-10-30 | No | No | Current |
| 72572-422-05 | 72572042205 | 5 SYRINGE in 1 CARTON (72572-422-05) / 3 mL in 1 SYRINGE | 5 syringe | 2025-10-30 | No | No | Current |