What is NDC 0310-4600?

0310-4600 is the product NDC for Bevespi Aerosphere, Glycopyrrolate 9 ug/1; Formoterol fumarate 4.8 ug/1 aerosol, metered, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bevespi Aerosphere (Glycopyrrolate and formoterol fumarate).

What is the active ingredient?

Glycopyrrolate, Formoterol fumarate.

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 Bevespi Aerosphere?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bevespi Aerosphere NDC 0310-4600 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0310-4600Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00310-4600Add 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	Copy
0310-4600-12	0031046001200310460012	120 AEROSOL, METERED in 1 INHALER (0310-4600-12)Marketed from Oct 3, 2016

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): Bevespi Aerosphere
Generic name (nonproprietary): glycopyrrolate and formoterol fumarate
Active ingredients: Glycopyrrolate — 9 ug/1Formoterol fumarate — 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 208294
Marketing start: Oct 3, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0310-4600_90a24746-75fb-490b-9e0d-7e33a5d8f00aSPL ID 90a24746-75fb-490b-9e0d-7e33a5d8f00aSPL set ID ae02436e-9528-490e-a844-0c0f6f2843f9RxCUI 1790639, 1790644UNII V92SO9WP2I, W34SHF8J2K
Pharmacologic class: Anticholinergic; Cholinergic Muscarinic Antagonist; 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

N400310460012 followed by a unit qualifier and the quantity

Package 00310-4600-12. 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 Mar 24, 2023.

Indications (excerpt from the label)

BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.2 )] . BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.1 , 5.2 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0310-4600

What is NDC 0310-4600?: 0310-4600 is the product NDC for Bevespi Aerosphere, Glycopyrrolate 9 ug/1; Formoterol fumarate 4.8 ug/1 aerosol, metered, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bevespi Aerosphere (Glycopyrrolate and formoterol fumarate).
What is the active ingredient?: Glycopyrrolate, Formoterol fumarate.
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 Bevespi Aerosphere?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Bevespi Aerosphere (Glycopyrrolate and formoterol fumarate) NDC 0310-4600