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NDC 00310-9400-01 WAINUA 45 mg/45mg Details
WAINUA 45 mg/45mg
WAINUA is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is EPLONTERSEN.
Product Information
| NDC | 00310-9400 |
|---|---|
| Product ID | 0310-9400_d7dcb847-71dd-4fff-82d0-d43a465fc096 |
| Associated GPIs | |
| GCN Sequence Number | 085619 |
| GCN Sequence Number Description | eplontersen sodium AUTO INJCT 45MG/0.8ML SUBCUT |
| HIC3 | P9B |
| HIC3 Description | AMYLOIDOSIS AGENTS-TRANSTHYRETIN (TTR) SUPPRESSION |
| GCN | 55135 |
| HICL Sequence Number | 049355 |
| HICL Sequence Number Description | EPLONTERSEN SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | WAINUA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | EPLONTERSEN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 45 |
| Active Ingredient Units | mg/45mg |
| Substance Name | EPLONTERSEN |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA217388 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-9400-01 (00310940001)
| NDC Package Code | 0310-9400-01 |
|---|---|
| Billing NDC | 00310940001 |
| Package | 45 mg in 1 SYRINGE, GLASS (0310-9400-01) |
| Marketing Start Date | 2023-12-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |