BEVESPI AEROSPHERE
- Product NDC
- 0310-4600
- 11-digit product format
- 003104600
- Labeler code
- 0310
- Product ID
- 0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate and formoterol fumarate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA208294
- Marketing category
- NDA
- Marketing start
- 2016-10-03
- Substance
- FORMOTEROL FUMARATE; GLYCOPYRROLATE
- Active strength
- 4.8; 9 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [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
- BEVESPI AEROSPHERE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FORMOTEROL FUMARATE | 4.8 ug/1 |
| GLYCOPYRROLATE | 9 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W34SHF8J2K, V92SO9WP2I |
| Rxcui | 1790639, 1790644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-4600-12 | BEVESPI AEROSPHERE | 120 in 1 INHALER | AEROSOL, METERED | 120 | | 26 |
| 0310-4600-28 | BEVESPI AEROSPHERE | 28 in 1 INHALER | AEROSOL, METERED | 28 | | 26 |
| 0310-4600-39 | BEVESPI AEROSPHERE | 28 in 1 INHALER | AEROSOL, METERED | 28 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-4600 | BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE) AEROSOL, METERED [ASTRAZENECA PHARMACEUTICALS LP] | 24 | Current NDC, Legacy NDC, 3 package rows | 20241120_ae02436e-9528-490e-a844-0c0f6f2843f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-4600-12 | 00310460012 | 120 AEROSOL, METERED in 1 INHALER (0310-4600-12) | 2016-10-03 | 0000-00-00 | No | No | Current |
| 0310-4600-28 | 00310460028 | 28 AEROSOL, METERED in 1 INHALER (0310-4600-28) | 2017-05-01 | 0000-00-00 | No | No | Current |
| 0310-4600-39 | 00310460039 | 28 AEROSOL, METERED in 1 INHALER (0310-4600-39) | 2017-08-01 | 0000-00-00 | No | No | Current |