Formoterol Fumarate
- Product NDC
- 43598-778
- 11-digit product format
- 435980778
- Labeler code
- 43598
- Product ID
- 43598-778_a38c72c4-21fd-6f2a-6219-ac4cb84e4ddd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- formoterol fumarate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA215907
- Marketing category
- ANDA
- Marketing start
- 2025-01-30
- 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 |
|---|
| 43598-778-11 | Formoterol Fumarate | 1 in 1 POUCH | SOLUTION | 1 | | 7 |
| 43598-778-11 | Formoterol Fumarate | 2 mL in 1 VIAL | SOLUTION | 2 | | 7 |
| 43598-778-30 | Formoterol Fumarate | 30 in 1 CARTON | SOLUTION | 30 | | 7 |
| 43598-778-60 | Formoterol Fumarate | 60 in 1 CARTON | SOLUTION | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-778 | FORMOTEROL FUMARATE SOLUTION [DR. REDDY'S LABORATORIES INC.] | 7 | Current NDC, 4 package rows | 20250202_2010b5cb-c277-57dd-ed6b-607cad2c45a4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-778-11 | 43598077811 | 1 in 1 POUCH | | | | | Historical |
| 43598-778-30 | 43598077830 | 30 POUCH in 1 CARTON (43598-778-30) / 1 VIAL in 1 POUCH (43598-778-11) / 2 mL in 1 VIAL | 30 pouch | 2025-01-30 | No | No | Current |
| 43598-778-60 | 43598077860 | 60 POUCH in 1 CARTON (43598-778-60) / 1 VIAL in 1 POUCH (43598-778-11) / 2 mL in 1 VIAL | 60 pouch | 2025-01-30 | No | No | Current |