Breo Ellipta
- Product NDC
- 70518-2028
- 11-digit product format
- 705182028
- Labeler code
- 70518
- Product ID
- 70518-2028_e3883c75-1d1c-1744-e053-2a95a90a504e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone furoate and vilanterol trifenatate
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- REMEDYREPACK INC.
- Application
- NDA204275
- Marketing category
- NDA
- Marketing start
- 2019-04-17
- Marketing end
- 0000-00-00
- Substance
- FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
- Active strength
- 100 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2028-0 | 70518202800 | 1 TRAY in 1 CARTON (70518-2028-0) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER | 1 tray | 2019-04-17 | 0000-00-00 | No | No | Current |