Glycopyrrolate NDC 55111-648

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0648Add 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
55111-648-01	55111064801	100 TABLET in 1 BOTTLE (55111-648-01)Marketed from Jul 14, 2008
55111-648-05	55111064805	500 TABLET in 1 BOTTLE (55111-648-05)Marketed from Jul 14, 2008

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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040847
Marketing start: Jul 14, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 55111-648_51baf5c0-1517-06f6-3102-47df40906299SPL ID 51baf5c0-1517-06f6-3102-47df40906299SPL set ID 725529e8-9c4b-4108-690a-e4f391439736RxCUI 197738UNII V92SO9WP2I
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

N455111064801 followed by a unit qualifier and the quantity

Package 55111-0648-01. 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 Nov 15, 2016.

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 040847

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

FDA NDC Directory listings under ANDA 040847
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-649