Prescription drug · ANDA
Breyna (Budesonide and formoterol fumarate) NDC 0378-7503
Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7503-32 | 0037875033200378750332 | 1 POUCH in 1 CARTON (0378-7503-32) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTERMarketed from Jul 31, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Breyna
- Generic name (nonproprietary)
- budesonide and formoterol fumarate
- Active ingredients
- Budesonide — 160 ug/1Formoterol fumarate — 4.5 ug/1
- Dosage form
- Aerosol, Metered
- Route
- Respiratory (Inhalation)
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211699
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0378-7503_c9fc3541-8929-4517-9a4e-969fca81e390SPL ID c9fc3541-8929-4517-9a4e-969fca81e390SPL set ID dc529fc4-bddb-4673-8202-dc401f86166fRxCUI 1246288, 1246304, 2597670, 2597673UNII W34SHF8J2K, Q3OKS62Q6X
- Pharmacologic class
- Corticosteroid; beta2-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400378750332followed by a unit qualifier and the quantityPackage 00378-7503-32. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BREYNA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma BREYNA is indicated for the treatment of asthma in patients 6 years of age and older. BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled…
Excerpt only. Read the full label for complete information.
About NDC 0378-7503
- What is NDC 0378-7503?
- 0378-7503 is the product NDC for Breyna, Budesonide 160 ug/1; Formoterol fumarate 4.5 ug/1 aerosol, metered, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Breyna (Budesonide and Formoterol Fumarate).
- What is the active ingredient?
- Budesonide, Formoterol fumarate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Breyna?
- 1 other product NDC are listed under this name. See all Breyna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Breyna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Breynabudesonide and formoterol fumarate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7502 | 00378-7502-32 |
Other NDCs under ANDA 211699
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Breynabudesonide and formoterol fumarate | Budesonide 80 ug/1; Formoterol fumarate 4.5 ug/1 | Aerosol, MeteredRespiratory (Inhalation) | Mylan Pharmaceuticals Inc. | 0378-7502 |