Ulspira
- Product NDC
- 82605-008
- 11-digit product format
- 826050008
- Labeler code
- 82605
- Product ID
- 82605-008_42659119-4ca6-acf0-e063-6294a90a52ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitric Oxide
- Dosage form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Airgas Therapeutics, LLC
- Application
- ANDA203144
- Marketing category
- ANDA
- Marketing start
- 2023-08-04
- Substance
- NITRIC OXIDE
- Active strength
- .8 mL/100L
- Pharmacologic classes
- Vasodilation [PE], Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ulspira
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITRIC OXIDE | .8 mL/100L |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31C4KY9ESH |
| Rxcui | 582608, 2702871 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82605-008-01 | Ulspira | 2138 L in 1 CYLINDER | GAS | 2138 | | 15 |
| 82605-008-02 | Ulspira | 362 L in 1 CYLINDER | GAS | 362 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82605-008 | ULSPIRA (NITRIC OXIDE) GAS [AIRGAS THERAPEUTICS, LLC] | 1 | Current NDC, 2 package rows | 20250124_2c605fc0-82be-09e0-e063-6394a90a63e9.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 |
|---|
| 82605-008-01 | 82605000801 | 2138 L in 1 CYLINDER (82605-008-01) | 2138 l | 2023-08-04 | No | No | Current |
| 82605-008-02 | 82605000802 | 362 L in 1 CYLINDER (82605-008-02) | 362 l | 2023-08-04 | No | No | Current |