Formoterol fumarate
- Product NDC
- 0093-4061
- 11-digit product format
- 000934061
- Labeler code
- 0093
- Product ID
- 0093-4061_0ecd7fc0-7e29-4502-91ff-a0ead5a5a1f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Formoterol fumarate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA091141
- Marketing category
- ANDA
- Marketing start
- 2021-06-22
- 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 |
|---|
| 0093-4061-06 | Formoterol fumarate | 1 in 1 POUCH | SOLUTION | 1 | | 3 |
| 0093-4061-06 | Formoterol fumarate | 60 in 1 CARTON | SOLUTION | 60 | | 3 |
| 0093-4061-19 | Formoterol fumarate | 2 mL in 1 VIAL | SOLUTION | 2 | | 3 |
| 0093-4061-19 | Formoterol fumarate | 1 in 1 POUCH | SOLUTION | 1 | | 3 |
| 0093-4061-30 | Formoterol fumarate | 30 in 1 CARTON | SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-4061 | FORMOTEROL FUMARATE SOLUTION [TEVA PHARMACEUTICALS USA, INC.] | 3 | Current NDC, Legacy NDC, 5 package rows | 20220709_419bc85d-8e24-478b-921e-babfb73e79f3.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 |
|---|
| 0093-4061-06 | 00093406106 | 60 POUCH in 1 CARTON (0093-4061-06) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL | 60 pouch | 2021-06-22 | 0000-00-00 | No | No | Current |
| 0093-4061-19 | 00093406119 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 0093-4061-30 | 00093406130 | 30 POUCH in 1 CARTON (0093-4061-30) / 1 VIAL in 1 POUCH (0093-4061-19) / 2 mL in 1 VIAL | 30 pouch | 2021-06-22 | 0000-00-00 | No | No | Current |