Cuvposa (glycopyrrolate) NDC 0259-0501

NDC codes

FDA NDC Directory

Product NDC (as listed)0259-0501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00259-0501Add 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
0259-0501-16	00259050116	1 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLEMarketed from Jan 1, 2013

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): Cuvposa
Generic name (nonproprietary): glycopyrrolate
Active ingredients: Glycopyrrolate — 1 mg/5mL
Dosage form: Liquid
Route: Oral
Labeler: Merz Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022571
Marketing start: Jan 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0259-0501_811238a3-579a-4f73-92a4-dbbc1f2d9548SPL ID 811238a3-579a-4f73-92a4-dbbc1f2d9548SPL set ID d200bd44-9856-4104-a29e-a4cca3db6737RxCUI 999961, 999965UNII V92SO9WP2I
Pharmacologic class: Anticholinergic; Cholinergic Muscarinic Antagonist

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400259050116 followed by a unit qualifier and the quantity

Package 00259-0501-16. 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 Dec 19, 2024.

Indications (excerpt from the label)

CUVPOSA is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). CUVPOSA is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)