Prescription drug · ANDA
Glycopyrrolate NDC 63323-578
Glycopyrrolate .2 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-578-01 | 63323057801 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)Marketed from Oct 27, 2017 | |
| 63323-578-02 | 63323057802 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-578-04)Marketed from Oct 27, 2017 | |
| 63323-578-05 | 63323057805 | 25 VIAL, MULTI-DOSE in 1 CARTON (63323-578-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-578-07)Marketed from Oct 27, 2017 |
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, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209328
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763SPL ID 779dc924-ecc3-41cc-8cf9-a7354db4f763SPL set ID 54458620-d888-4df6-ae4b-78c3dfed3423RxCUI 238212, 1731582, 1731590UNII V92SO9WP2IUPC 0363323578046, 0363323578039, 0363323578077
- Pharmacologic class
- Anticholinergic
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
N463323057801followed by a unit qualifier and the quantityPackage 63323-0578-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE: 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 blockad…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209328
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 |
|---|---|---|---|---|
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-801 |