ProAir Digihaler
- Product NDC
- 59310-117
- 11-digit product format
- 593100117
- Labeler code
- 59310
- Product ID
- 59310-117_6d6a3e12-ee60-4cec-9f1b-df00c47b769f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- albuterol sulfate
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Respiratory, LLC
- Application
- NDA205636
- Marketing category
- NDA
- Marketing start
- 2019-10-04
- Substance
- ALBUTEROL SULFATE
- Active strength
- 90 ug/1
- 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
- ProAir Digihaler
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUTEROL SULFATE | 90 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 021SEF3731 |
| Rxcui | 2166796, 2166797 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59310-117-20 | ProAir Digihaler | 1 in 1 BOX | INHALANT | 1 | | 26 |
| 59310-117-20 | ProAir Digihaler | 200 in 1 INHALER | INHALANT | 200 | | 26 |
| 59310-117-21 | ProAir Digihaler | 200 in 1 INHALER | INHALANT | 200 | | 26 |
| 59310-117-21 | ProAir Digihaler | 1 in 1 BOX | INHALANT | 1 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59310-117 | PROAIR DIGIHALER (ALBUTEROL SULFATE) POWDER, METERED PROAIR DIGIHALER (ALBUTEROL SULFATE) INHALANT [TEVA RESPIRATORY, LLC] | 26 | Current NDC, Legacy NDC, 4 package rows | 20240515_667ce3ec-5217-4b10-b712-f3e54fbbf087.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 |
|---|
| 59310-117-20 | 59310011720 | 1 INHALER in 1 BOX (59310-117-20) / 200 INHALANT in 1 INHALER | 1 inhaler | 2019-10-04 | 0000-00-00 | No | No | Current |
| 59310-117-21 | 59310011721 | 200 in 1 INHALER | | | | | | Historical |