Nucala
- Product NDC
- 0173-0892
- 11-digit product format
- 001730892
- Labeler code
- 0173
- Product ID
- 0173-0892_869b75ba-b2a0-406e-9ed2-136b75763d78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mepolizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- GlaxoSmithKline LLC
- Application
- BLA761122
- Marketing category
- BLA
- Marketing start
- 2019-06-06
- Substance
- MEPOLIZUMAB
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nucala
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEPOLIZUMAB | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 90Z2UF0E52 |
| Rxcui | 1720601, 1720606, 2170990, 2170993, 2173820, 2173822, 2596444, 2596445 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0173-0892-01 | Nucala | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-01 | Nucala | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-42 | Nucala | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-42 | Nucala | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-61 | Nucala | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-61 | Nucala | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-63 | Nucala | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 24 |
| 0173-0892-63 | Nucala | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MEPOLIZUMAB | ACTIVE INGREDIENT | 90Z2UF0E52 | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 2 | |
| MEPOLIZUMAB | ACTIVE MOIETY | 90Z2UF0E52 | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 2 | |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | INACTIVE INGREDIENT | 70WT22SF4B | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION [GLAXOSMITHKLINE LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0173-0892 | NUCALA (MEPOLIZUMAB) INJECTION, POWDER, FOR SOLUTION NUCALA (MEPOLIZUMAB) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | 22 | Current NDC, Legacy NDC, 8 package rows | 20250524_fefb887c-e4ac-431e-8893-e9d1a5a63fea.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 |
|---|
| 0173-0892-01 | 00173089201 | 1 SYRINGE in 1 CARTON (0173-0892-01) / 1 mL in 1 SYRINGE | 1 syringe | 2019-06-06 | 0000-00-00 | No | No | Current |
| 0173-0892-42 | 00173089242 | 1 SYRINGE in 1 CARTON (0173-0892-42) / 1 mL in 1 SYRINGE | 1 syringe | 2019-06-06 | 0000-00-00 | No | No | Current |
| 0173-0892-61 | 00173089261 | 1 SYRINGE in 1 CARTON (0173-0892-61) / 1 mL in 1 SYRINGE | 1 syringe | 2019-06-06 | 0000-00-00 | No | No | Current |
| 0173-0892-63 | 00173089263 | 1 SYRINGE in 1 CARTON (0173-0892-63) / 1 mL in 1 SYRINGE | 1 syringe | 2019-06-06 | 0000-00-00 | No | No | Current |