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NDC 00173-0915-61 ZEJULA 300 mg/1 Details
ZEJULA 300 mg/1
ZEJULA is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GlaxoSmithKline LLC. The primary component is NIRAPARIB TOSYLATE MONOHYDRATE.
Product Information
| NDC | 00173-0915 |
|---|---|
| Product ID | 0173-0915_b680e033-3428-436a-9999-4f851ec717a9 |
| Associated GPIs | |
| GCN Sequence Number | 084703 |
| GCN Sequence Number Description | niraparib tosylate TABLET 300 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 54057 |
| HICL Sequence Number | 044177 |
| HICL Sequence Number Description | NIRAPARIB TOSYLATE |
| Brand/Generic | Brand |
| Proprietary Name | ZEJULA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | niraparib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | NIRAPARIB TOSYLATE MONOHYDRATE |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA214876 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00173-0915-61 (00173091561)
| NDC Package Code | 0173-0915-61 |
|---|---|
| Billing NDC | 00173091561 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0915-61) |
| Marketing Start Date | 2023-06-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |