Glycopyrrolate NDC 15955-318

NDC codes

FDA NDC Directory

Product NDC (as listed)15955-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width15955-0318Add 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
15955-318-01	15955031801	100 TABLET in 1 BOTTLE, PLASTIC (15955-318-01)Marketed from Oct 19, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Glycopyrrolate
Generic name (nonproprietary): glycopyrrolate
Active ingredients: Glycopyrrolate — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Labs LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203657
Marketing start: Oct 19, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 15955-318_adf69aaa-e03b-419a-ac5b-e7b80cab3668SPL ID adf69aaa-e03b-419a-ac5b-e7b80cab3668SPL set ID db178372-51d2-4194-bbe2-da9acb1cfd53RxCUI 197738, 197739UNII V92SO9WP2IUPC 0315955318019, 0315955305019
Pharmacologic class: Anticholinergic

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

N415955031801 followed by a unit qualifier and the quantity

Package 15955-0318-01. 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 9, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203657

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

FDA NDC Directory listings under ANDA 203657
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Alembic Labs LLC	15955-305