Glycopyrrolate NDC 76045-023

NDC codes

FDA NDC Directory

Product NDC (as listed)76045-023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76045-0023Add 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
76045-023-30	76045002330	10 SYRINGE in 1 CARTON (76045-023-30) / 3 mL in 1 SYRINGE (76045-023-00)Marketed from Apr 21, 2022

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/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214919
Marketing start: Apr 21, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 76045-023_1925138e-94b7-4e29-815e-f6681943a734SPL ID 1925138e-94b7-4e29-815e-f6681943a734SPL set ID 685aaf64-1a64-42f9-a96f-4764d650c26fRxCUI 2473383UNII V92SO9WP2I
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

N476045002330 followed by a unit qualifier and the quantity

Package 76045-0023-30. 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 May 14, 2024.

Indications (excerpt from the label)

Glycopyrrolate Injection, USP (0.2 mg/mL) is an anticholinergic indicated for use in: anesthesia (all ages) for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, and for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents. peptic ulcer (adults) as adjunctive therapy for the treatment of peptic ulcer when…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 214919

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

FDA NDC Directory listings under NDA 214919
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	76045-223