What is NDC 0517-4605?

0517-4605 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

American Regent, Inc., NDC labeler code 0517. 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 0517-4605 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-4605Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-4605Add 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
0517-4605-25	00517460525	25 VIAL, MULTI-DOSE in 1 TRAY (0517-4605-25) / 5 mL in 1 VIAL, MULTI-DOSE (0517-4605-01)Marketed from Sep 30, 1990

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): Glycopyrrolate
Generic name (nonproprietary): glycopyrrolate
Active ingredients: Glycopyrrolate — .2 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089335
Marketing start: Sep 30, 1990
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 0517-4605_717932bc-0c76-4910-8476-8d1e42b7a8feSPL ID 717932bc-0c76-4910-8476-8d1e42b7a8feSPL set ID 62267afe-1a73-4623-984e-646db590ec5bRxCUI 238212, 1731582, 1731590UNII V92SO9WP2IUPC 0305174601252, 0305174605250, 0305174602259, 0305174620253
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400517460525 followed by a unit qualifier and the quantity

Package 00517-4605-25. 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 Feb 7, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE In Anesthesia: Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular bloc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0517-4605

What is NDC 0517-4605?: 0517-4605 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. 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?: American Regent, Inc., NDC labeler code 0517. 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 089335

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

FDA NDC Directory listings under ANDA 089335
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	American Regent, Inc.	0517-4601
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Civica, Inc.	72572-226
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	American Regent, Inc.	0517-4602
Glycopyrrolate	Glycopyrrolate .2 mg/mL	Injection, SolutionIntramuscular, Intravenous	American Regent, Inc.	0517-4620