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NDC 71336-1001-01 GIVLAARI 189 mg/mL Details
GIVLAARI 189 mg/mL
GIVLAARI is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alnylam Pharmaceuticals, Inc.. The primary component is GIVOSIRAN SODIUM.
Product Information
| NDC | 71336-1001 |
|---|---|
| Product ID | 71336-1001_c47a10ee-f647-4319-85e9-8b7505637bde |
| Associated GPIs | 85080025202020 |
| GCN Sequence Number | 080500 |
| GCN Sequence Number Description | givosiran sodium VIAL 189 MG/ML SUBCUT |
| HIC3 | D7K |
| HIC3 Description | DRUGS TO TREAT ACUTE HEPATIC PORPHYRIA (AHP) |
| GCN | 47364 |
| HICL Sequence Number | 046222 |
| HICL Sequence Number Description | GIVOSIRAN SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | GIVLAARI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | givosiran sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 189 |
| Active Ingredient Units | mg/mL |
| Substance Name | GIVOSIRAN SODIUM |
| Labeler Name | Alnylam Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA212194 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71336-1001-01 (71336100101)
| NDC Package Code | 71336-1001-1 |
|---|---|
| Billing NDC | 71336100101 |
| Package | 1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2019-12-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |