GIVLAARI
- Product NDC
- 71336-1001
- 11-digit product format
- 713361001
- Labeler code
- 71336
- Product ID
- 71336-1001_942492a0-de6e-4c31-8b9c-d259f808d821
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- givosiran sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Alnylam Pharmaceuticals, Inc.
- Application
- NDA212194
- Marketing category
- NDA
- Marketing start
- 2019-12-12
- Substance
- GIVOSIRAN SODIUM
- Active strength
- 189 mg/mL
- Pharmacologic classes
- Aminolevulinate Synthase 1-directed RNA Interaction [EPC], Decreased RNA Integrity [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GIVLAARI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GIVOSIRAN SODIUM | 189 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5XE21E41RT |
| Rxcui | 2265716, 2265721 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71336-1001-1 | GIVLAARI | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | | 14 |
| 71336-1001-1 | GIVLAARI | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71336-1001 | GIVLAARI (GIVOSIRAN SODIUM) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240511_167e663c-11e1-497b-a3fc-951d65d58eaa.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 |
|---|
| 71336-1001-1 | 71336100101 | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE | 2019-12-12 | 0000-00-00 | No | No | Current |