Prescription drug · NDA
Glyrx-PF (Glycopyrrolate) NDC 51754-6001
Glycopyrrolate .2 mg/mL · Injection, Solution · Intramuscular, Intravenous · Exela Pharma Sciences, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51754-6001-4 | 5175460010451754600104 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6001-4) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Glyrx-PF
- Generic name (nonproprietary)
- glycopyrrolate
- Active ingredients
- Glycopyrrolate — .2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Exela Pharma Sciences, LLCNDC labeler code 51754
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210997
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 51754-6001_442634f7-9858-421d-91db-5bfdb21dcf13SPL ID 442634f7-9858-421d-91db-5bfdb21dcf13SPL set ID 2189f3f5-39dc-4e85-b7c6-9515ded59686RxCUI 1731582, 1731590, 2371710, 2371715, 2371718, 2371796, 2473383, 2473384UNII 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.
- NDC on a medical claim
N451754600104followed by a unit qualifier and the quantityPackage 51754-6001-04. 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 .
Indications (excerpt from the label)
GLYRX ® -PF is indicated: 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. in peptic ulcer (adults) • To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic…
Excerpt only. Read the full label for complete information.
About NDC 51754-6001
- What is NDC 51754-6001?
- 51754-6001 is the product NDC for Glyrx-PF (glycopyrrolate), Glycopyrrolate .2 mg/mL injection, solution, listed with the FDA by Exela Pharma Sciences, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glyrx-PF (Glycopyrrolate).
- What is the active ingredient?
- Glycopyrrolate.
- Who is the labeler?
- Exela Pharma Sciences, LLC, NDC labeler code 51754. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glyrx-PF?
- 3 other product NDCs are listed under this name. See all Glyrx-PF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glyrx-PF products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6013 | 51754-6013-03 |
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6015 | 51754-6015-03 |
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6000 | 51754-6000-04 |
Other NDCs under NDA 210997
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6000 |
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6013 |
| Glyrx-PFglycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Exela Pharma Sciences, LLC | 51754-6015 |