What is NDC 69315-140?

69315-140 is the product NDC for Glycopyrrolate, Glycopyrrolate 2 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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?

182 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 69315-140 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-140Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0140Add 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
69315-140-01	6931501400169315014001	100 TABLET in 1 BOTTLE (69315-140-01)Marketed from Sep 22, 2018

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: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090195
Marketing start: Sep 22, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 69315-140_2de7338c-edc9-49b2-8f4a-7f29736595b0SPL ID 2de7338c-edc9-49b2-8f4a-7f29736595b0SPL set ID 498bce66-6072-4212-8413-ff9888c58f9cRxCUI 197738, 197739UNII V92SO9WP2IUPC 0369315139011, 0369315140017
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

N469315014001 followed by a unit qualifier and the quantity

Package 69315-0140-01. 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 Apr 25, 2025.

Indications (excerpt from the label)

Glycopyrrolate Tablets, USP are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate Tablets, USP are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate tablets, USP are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-140

What is NDC 69315-140?: 69315-140 is the product NDC for Glycopyrrolate, Glycopyrrolate 2 mg/1 tablet, listed with the FDA by Leading Pharma, LLC. 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?: Leading Pharma, LLC, NDC labeler code 69315. 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?: 182 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 183 Glycopyrrolate NDCs

Other NDCs under ANDA 090195

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

FDA NDC Directory listings under ANDA 090195
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Leading Pharma, LLC	69315-139
Glycopyrrolate	Glycopyrrolate 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-9652