Umeclidinium Ellipta
- Product NDC
- 66993-189
- 11-digit product format
- 669930189
- Labeler code
- 66993
- Product ID
- 66993-189_78029af6-3c01-4be0-8439-ec3c22b4abb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- umeclidinium
- Dosage form
- AEROSOL, POWDER
- Route
- ORAL
- Labeler
- Prasco Laboratories
- Application
- NDA205382
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2026-04-06
- Substance
- UMECLIDINIUM BROMIDE
- Active strength
- 62.5 ug/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Umeclidinium Ellipta
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| UMECLIDINIUM BROMIDE | 62.5 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AN603V4JV |
| Rxcui | 1539251 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66993-189-97 | Umeclidinium Ellipta | 1 in 1 CARTON | AEROSOL, POWDER | 1 | | 2 |
| 66993-189-97 | Umeclidinium Ellipta | 1 in 1 TRAY | AEROSOL, POWDER | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66993-189-97 | 66993018997 | 1 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER | 1 tray | 2026-04-06 | No | No | Historical |