BREYNA
- Product NDC
- 0378-7503
- 11-digit product format
- 003787503
- Labeler code
- 0378
- Product ID
- 0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA211699
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 160; 4.5 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BREYNA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUDESONIDE | 160 ug/1 |
| FORMOTEROL FUMARATE | 4.5 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q3OKS62Q6X, W34SHF8J2K |
| Rxcui | 1246288, 1246304, 2597670, 2597673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7503-32 | BREYNA | 1 in 1 CARTON | AEROSOL, METERED | 1 | | 5 |
| 0378-7503-32 | BREYNA | 1 in 1 POUCH | AEROSOL, METERED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7503 | BREYNA (BUDESONIDE AND FORMOTEROL FUMARATE) AEROSOL, METERED [MYLAN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250224_dc529fc4-bddb-4673-8202-dc401f86166f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2597670 | Breyna 160 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT | PSN | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 2597673 | Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT | PSN | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246304 | budesonide/formoterol fumarate 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246288 | budesonide/formoterol fumarate 80/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 2597673 | 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Breyna] | SBD | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 2597670 | 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler [Breyna] | SBD | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246288 | 120 ACTUAT budesonide 0.08 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler | SCD | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246304 | 120 ACTUAT budesonide 0.16 MG/ACTUAT / formoterol fumarate 0.0045 MG/ACTUAT Metered Dose Inhaler | SCD | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 2597670 | Breyna 160/4.5 MCG/INHAL Metered Dose Inhaler, 120 Actuations | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 2597673 | Breyna 80 MCG / 4.5 MCG Metered Dose Inhaler, 120 ACTUAT | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246288 | budesonide 0.08 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246304 | budesonide 0.16 MG / formoterol fumarate 0.0045 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246304 | budesonide 160 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
| 1246288 | budesonide 80 MCG / formoterol fumarate 4.5 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | dc529fc4-bddb-4673-8202-dc401f86166f | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-7503-32 | 00378750332 | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER | 1 pouch | 2023-07-31 | No | No | Current |