What is NDC 0310-4616?

0310-4616 is the product NDC for Breztri, Budesonide 160 ug/1 + 2 more ingredients aerosol, metered, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Breztri (Budesonide, glycopyrrolate, and formoterol fumarate).

What is the active ingredient?

Budesonide, Glycopyrrolate, Formoterol.

AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Breztri?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Breztri NDC 0310-4616 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-4616Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-4616Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0310-4616-12	0031046161200310461612	120 AEROSOL, METERED in 1 INHALER (0310-4616-12)Marketed from Jul 23, 2020
0310-4616-28	0031046162800310461628	28 AEROSOL, METERED in 1 INHALER (0310-4616-28)Marketed from Jul 23, 2020 · Sample package
0310-4616-39	0031046163900310461639	28 AEROSOL, METERED in 1 INHALER (0310-4616-39)Marketed from Jul 23, 2020

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): Breztri
Generic name (nonproprietary): budesonide, glycopyrrolate, and formoterol fumarate
Active ingredients: Budesonide — 160 ug/1Glycopyrrolate — 9 ug/1Formoterol — 4.8 ug/1
Dosage form: Aerosol, Metered
Route: Respiratory (Inhalation)
Labeler: AstraZeneca Pharmaceuticals LPNDC labeler code 0310
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212122
Marketing start: Jul 23, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0310-4616_0437e8e6-972d-4b1b-885c-ed28c5c43214SPL ID 0437e8e6-972d-4b1b-885c-ed28c5c43214SPL set ID 715433dc-cb2b-43ea-b6df-c5b4177adc6cRxCUI 2387326, 2387328, 2387329, 2387331, 2741705, 2741708, 2741710, 2741711UNII 5ZZ84GCW8B, V92SO9WP2I, Q3OKS62Q6X
Pharmacologic class: Anticholinergic; Cholinergic Muscarinic Antagonist; 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

N400310461612 followed by a unit qualifier and the quantity

Package 00310-4616-12. 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 Apr 27, 2026.

Indications (excerpt from the label)

BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1.1 ) • the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.3 , 5.1 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREZTRI AEROSPHERE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0310-4616

What is NDC 0310-4616?: 0310-4616 is the product NDC for Breztri, Budesonide 160 ug/1 + 2 more ingredients aerosol, metered, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Breztri (Budesonide, glycopyrrolate, and formoterol fumarate).
What is the active ingredient?: Budesonide, Glycopyrrolate, Formoterol.
Who is the labeler?: AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Breztri?: 1 other product NDC are listed under this name. See all Breztri NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Breztri NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Breztribudesonide, glycopyrrolate, and formoterol fumarate	Budesonide 160 ug/1 + 2 more ingredients	Aerosol, MeteredRespiratory (Inhalation)	AstraZeneca Pharmaceuticals LP	0310-6616	00310-6616-0100310-6616-3900310-6616-95

Other NDCs under NDA 212122

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 212122
Product	Strength	Form · route	Labeler	Product NDC
Breztribudesonide, glycopyrrolate, and formoterol fumarate	Budesonide 160 ug/1 + 2 more ingredients	Aerosol, MeteredRespiratory (Inhalation)	AstraZeneca Pharmaceuticals LP	0310-6616