What is NDC 69076-475?

69076-475 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/1 tablet, listed with the FDA by Quinn Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Quinn Pharmaceuticals, NDC labeler code 69076. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Glycopyrrolate?

179 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glycopyrrolate NDC 69076-475 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69076-475Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69076-0475Add 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
69076-475-01	6907604750169076047501	100 TABLET in 1 BOTTLE (69076-475-01)Marketed from May 1, 2021

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: Quinn PharmaceuticalsNDC labeler code 69076
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091182
Marketing start: May 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 69076-475_f03d88ab-275e-39b2-e053-2a95a90a22a6SPL ID f03d88ab-275e-39b2-e053-2a95a90a22a6SPL set ID e1ded8e0-c05b-4bf4-a129-57d1726af6edRxCUI 197738, 197739UNII V92SO9WP2IUPC 0369076475014, 0369076476011
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

N469076047501 followed by a unit qualifier and the quantity

Package 69076-0475-01. 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 20, 2022.

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)

About NDC 69076-475

What is NDC 69076-475?: 69076-475 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/1 tablet, listed with the FDA by Quinn Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Glycopyrrolate.
What is the active ingredient?: Glycopyrrolate.
Who is the labeler?: Quinn Pharmaceuticals, NDC labeler code 69076. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glycopyrrolate?: 179 other product NDCs are listed under this name. See all Glycopyrrolate 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 Glycopyrrolate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Glycopyrrolate	Glycopyrrolate 1 mg/5mL	SolutionOral	QUAGEN PHARMACEUTICALS LLC	70752-175	70752-0175-12
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4671	70518-4671-00
glycopyrrolate	Glycopyrrolate 1 mg/5mL	SolutionOral	Bionpharma Inc.	69452-406	69452-0406-88
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-4597	70518-4597-00
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-110	71921-0110-01
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-111	71921-0111-01
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Jvet Pharmaceuticals LLC	86211-113	86211-0113-10
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4537	70518-4537-00
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9776	00404-9776-05
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9777	00404-9777-20

All 180 Glycopyrrolate NDCs

Other NDCs under ANDA 091182

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

FDA NDC Directory listings under ANDA 091182
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-666
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	Quinn Pharmaceuticals	69076-476
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-1225
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-110
Glycopyrrolate	Glycopyrrolate 2 mg/1	TabletOral	Florida Pharmaceutical Products, LLC	71921-111