What is NDC 68083-378?

68083-378 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-378 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0378Add 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
68083-378-25	6808303782568083037825	25 VIAL in 1 CARTON (68083-378-25) / 5 mL in 1 VIAL (68083-378-01)Marketed from Oct 9, 2019

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: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212612
Marketing start: Oct 9, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 68083-378_92de5a0f-2918-4f66-a087-535c2dd0b3bdSPL ID 92de5a0f-2918-4f66-a087-535c2dd0b3bdSPL set ID d670bd26-8a44-44be-90e1-107d4c380233RxCUI 238212, 1731582, 1731590UNII V92SO9WP2IUPC 0368083379018
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

N468083037825 followed by a unit qualifier and the quantity

Package 68083-0378-25. 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 Apr 28, 2026.

Indications (excerpt from the label)

Glycopyrrolate Injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) • 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. • for protection against peripheral muscarinic effects of cholinergic agents. ( 1 ) in peptic ulcer (adults) • To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated. Limi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-378

What is NDC 68083-378?: 68083-378 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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 212612

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

FDA NDC Directory listings under ANDA 212612
Product	Strength	Form · route	Labeler	Product NDC
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-376
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-377
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-379
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed LLC	70700-165
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed LLC	70700-166
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed LLC	70700-167
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed LLC	70700-168
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed, LLC	70700-902
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Xiromed, LLC	70700-903
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7224
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7292
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Medical Purchasing Solutions, LLC	71872-7307
Glycopyrrolate	Glycopyrrolate .2 mg/mL	InjectionIntramuscular, Intravenous	Jvet Pharmaceuticals LLC	86211-113