Sinuva
- Product NDC
- 10599-003
- 11-digit product format
- 105990003
- Labeler code
- 10599
- Product ID
- 10599-003_508796b2-418c-402f-a33f-5766a8d4c18b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mometasone furoate
- Dosage form
- IMPLANT
- Route
- INTRASINAL
- Labeler
- Intersect ENT, Inc.
- Application
- NDA209310
- Marketing category
- NDA
- Marketing start
- 2018-02-01
- Substance
- MOMETASONE FUROATE
- Active strength
- 1350 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sinuva
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOMETASONE FUROATE | 1350 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04201GDN4R |
| Rxcui | 1995983, 1995988 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10599-003-01 | Sinuva | 1 in 1 POUCH | IMPLANT | 1 | | 3 |
| 10599-003-01 | Sinuva | 1 in 1 CARTON | IMPLANT | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10599-003 | SINUVA (MOMETASONE FUROATE) IMPLANT [INTERSECT ENT, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230127_e33c1b23-cdc6-4f64-94ba-24b0b42c09bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10599-003-01 | 10599000301 | 1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH | 1 pouch | 2018-02-01 | 0000-00-00 | No | No | Current |