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NDC 10599-0003-01 Sinuva 1350 ug/1 Details
Sinuva 1350 ug/1
Sinuva is a INTRASINAL IMPLANT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Intersect ENT, Inc.. The primary component is MOMETASONE FUROATE.
Product Information
| NDC | 10599-0003 |
|---|---|
| Product ID | 10599-003_508796b2-418c-402f-a33f-5766a8d4c18b |
| Associated GPIs | 42200045102350 |
| GCN Sequence Number | 078014 |
| GCN Sequence Number Description | mometasone furoate IMPLANT 1350 MCG NASAL |
| HIC3 | Q7P |
| HIC3 Description | NASAL ANTI-INFLAMMATORY STEROIDS |
| GCN | 44214 |
| HICL Sequence Number | 003329 |
| HICL Sequence Number Description | MOMETASONE FUROATE |
| Brand/Generic | Brand |
| Proprietary Name | Sinuva |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mometasone furoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | IMPLANT |
| Route | INTRASINAL |
| Active Ingredient Strength | 1350 |
| Active Ingredient Units | ug/1 |
| Substance Name | MOMETASONE FUROATE |
| Labeler Name | Intersect ENT, Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209310 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10599-0003-01 (10599000301)
| NDC Package Code | 10599-003-01 |
|---|---|
| Billing NDC | 10599000301 |
| Package | 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH |
| Marketing Start Date | 2018-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |