OXLUMO
- Product NDC
- 71336-1002
- 11-digit product format
- 713361002
- Labeler code
- 71336
- Product ID
- 71336-1002_6ef869cb-8ccd-4339-9991-0fab45da1fbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lumasiran
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Alnylam Pharmaceuticals, Inc.
- Application
- NDA214103
- Marketing category
- NDA
- Marketing start
- 2020-11-23
- Substance
- LUMASIRAN SODIUM
- Active strength
- 94.5 mg/.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXLUMO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUMASIRAN SODIUM | 94.5 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 67P6XH37HD |
| Rxcui | 2467153, 2467158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71336-1002-1 | OXLUMO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 71336-1002-1 | OXLUMO | 0.5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 0.5 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71336-1002 | OXLUMO (LUMASIRAN) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250412_16985a31-f5e4-4557-9266-fc78d4bc5055.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71336-1002-1 | 71336100201 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE | 2020-11-23 | 0000-00-00 | No | No | Current |