Arformoterol Tartrate
- Product NDC
- 50742-395
- 11-digit product format
- 507420395
- Labeler code
- 50742
- Product ID
- 50742-395_36d07bcc-852e-5e20-e063-6394a90aaa7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Arformoterol Tartrate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA218156
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- ARFORMOTEROL TARTRATE
- Active strength
- 15 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
- Arformoterol Tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARFORMOTEROL TARTRATE | 15 ug/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P8VJ2I235 |
| Rxcui | 668956 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50742-395-05 | Arformoterol Tartrate | 2 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 2 | | 3 |
| 50742-395-05 | Arformoterol Tartrate | 5 in 1 POUCH | SOLUTION | 5 | | 3 |
| 50742-395-30 | Arformoterol Tartrate | 5 in 1 POUCH | SOLUTION | 5 | | 3 |
| 50742-395-30 | Arformoterol Tartrate | 6 in 1 CARTON | SOLUTION | 6 | | 3 |
| 50742-395-60 | Arformoterol Tartrate | 12 in 1 CARTON | SOLUTION | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-395 | ARFORMOTEROL TARTRATE SOLUTION [INGENUS PHARMACEUTICALS, LLC] | 2 | Current NDC, 5 package rows | 20250306_9572582e-8cc2-4d3d-b9dc-c2b8159d71d8.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 |
|---|
| 50742-395-05 | 50742039505 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | Historical |
| 50742-395-30 | 50742039530 | 6 POUCH in 1 CARTON (50742-395-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE | 6 pouch | 2025-03-01 | No | No | Historical |
| 50742-395-60 | 50742039560 | 12 POUCH in 1 CARTON (50742-395-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-395-05) / 2 mL in 1 VIAL, SINGLE-DOSE | 12 pouch | 2025-03-01 | No | No | Historical |