Apidra SoloStar
- Product NDC
- 0088-2502
- 11-digit product format
- 000882502
- Labeler code
- 0088
- Product ID
- 0088-2502_6be54063-6912-4810-b1c7-dfca969224d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glulisine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- sanofi-aventis U.S. LLC
- Application
- BLA021629
- Marketing category
- BLA
- Marketing start
- 2009-02-24
- Substance
- INSULIN GLULISINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Apidra SoloStar
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN GLULISINE | 100 [iU]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7XIY785AZD |
| Rxcui | 485210, 803194, 847259, 847261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0088-2502-00 | Apidra SoloStar | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 28 |
| 0088-2502-01 | Apidra SoloStar | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 28 |
| 0088-2502-01 | Apidra SoloStar | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 28 |
| 0088-2502-05 | Apidra SoloStar | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| insulin glulisine | ACTIVE INGREDIENT | 7XIY785AZD | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| insulin glulisine | ACTIVE MOIETY | 7XIY785AZD | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| metacresol | INACTIVE INGREDIENT | GGO4Y809LO | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| tromethamine | INACTIVE INGREDIENT | 023C2WHX2V | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0088-2502 | APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] | 24 | Current NDC, Legacy NDC, 4 package rows | 20230728_e7af6a7a-8046-4fb4-9979-4ec4230b23aa.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 |
|---|
| 0088-2502-00 | 00088250200 | 3 mL in 1 SYRINGE, PLASTIC | 3 ml | | | | | Historical |
| 0088-2502-01 | 00088250201 | 1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTIC | | 2009-02-24 | 0000-00-00 | No | No | Current |
| 0088-2502-05 | 00088250205 | 5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00) | | 2009-02-24 | 0000-00-00 | No | No | Current |