Insulin Glargine
- Product NDC
- 83257-014
- 11-digit product format
- 832570014
- Labeler code
- 83257
- Product ID
- 83257-014_fb8ba940-aef7-d17f-6539-6f3a73ae3a72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin Glargine-yfgn
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Biocon Biologics Inc.
- Application
- BLA761201
- Marketing category
- BLA
- Marketing start
- 2023-07-28
- 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, 2563976 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83257-014-11 | Insulin Glargine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
| 83257-014-11 | Insulin Glargine | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83257-014 | INSULIN GLARGINE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.] | 8 | Current NDC, 2 package rows | 20250516_3ac85ebb-5594-59c8-77fd-df254329d151.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83257-014-11 | 83257001411 | 1 VIAL, MULTI-DOSE in 1 CARTON (83257-014-11) / 10 mL in 1 VIAL, MULTI-DOSE | 2023-07-28 | No | No | Historical |