SEMGLEE
- Product NDC
- 83257-012
- 11-digit product format
- 832570012
- Labeler code
- 83257
- Product ID
- 83257-012_3b749417-8933-850b-1373-990e7ee8a312
- 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
- Marketing end
- 2027-05-31
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SEMGLEE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN GLARGINE | 100 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2ZM8CX04RZ |
| Rxcui | 2563971, 2563973, 2563976, 2563977 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83257-012-31 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 14 |
| 83257-012-31 | SEMGLEE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
| 83257-012-32 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 14 |
| 83257-012-32 | SEMGLEE | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 14 |
| 83257-012-33 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 14 |
| 83257-012-33 | SEMGLEE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83257-012 | SEMGLEE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.] | 12 | Current NDC, 6 package rows | 20250516_8cf5544f-87d6-468b-f6ae-898b1fdb5d80.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 83257-012-31 | 83257001231 | 1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE | 1 syringe | 2023-07-28 | 2027-05-31 | No | No | Historical |
| 83257-012-32 | 83257001232 | 3 mL in 1 SYRINGE | 3 ml | | | | | Historical |
| 83257-012-33 | 83257001233 | 5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE | 5 syringe | 2023-07-28 | 2027-05-31 | No | No | Historical |