Formoterol fumarate
- Product NDC
- 73043-051
- 11-digit product format
- 730430051
- Labeler code
- 73043
- Product ID
- 73043-051_7f289241-a13a-4a5f-b579-7b15dbab3d44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Formoterol fumarate dihydrate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Devatis, Inc.
- Application
- ANDA218308
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- Substance
- FORMOTEROL FUMARATE
- Active strength
- 20 ug/2mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Formoterol fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FORMOTEROL FUMARATE | 20 ug/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W34SHF8J2K |
| Rxcui | 1246319 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73043-051-93 | Formoterol fumarate | 1 in 1 POUCH | SOLUTION | 1 | | 1 |
| 73043-051-93 | Formoterol fumarate | 30 in 1 CARTON | SOLUTION | 30 | | 1 |
| 73043-051-96 | Formoterol fumarate | 60 in 1 CARTON | SOLUTION | 60 | | 1 |
| 73043-051-96 | Formoterol fumarate | 1 in 1 POUCH | SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73043-051-93 | 73043005193 | 30 POUCH in 1 CARTON (73043-051-93) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL | 30 pouch | 2025-06-30 | No | No | Historical |
| 73043-051-96 | 73043005196 | 60 POUCH in 1 CARTON (73043-051-96) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL | 60 pouch | 2025-06-30 | No | No | Historical |