Prescription drug · ANDA
Glycopyrrolate NDC 43547-640
Glycopyrrolate .4 mg/2mL · Injection · Intramuscular, Intravenous · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-640-25 | 43547064025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (43547-640-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43547-640-01)Marketed from May 1, 2021 |
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 — .4 mg/2mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210927
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 43547-640_8a403c54-3e23-41fc-bf80-c40e8d867aa2SPL ID 8a403c54-3e23-41fc-bf80-c40e8d867aa2SPL set ID 2972f22e-378c-450b-8869-1354a9bd0ffcRxCUI 1731582, 1731590UNII V92SO9WP2IUPC 0343547639013, 0343547640019
- 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
N443547064025followed by a unit qualifier and the quantityPackage 43547-0640-25. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210927
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 .4 mg/2mL | InjectionIntramuscular, Intravenous | Solco Healthcare US, LLC | 43547-544 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Solco Healthcare US, LLC | 43547-543 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7208 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Solco Healthcare US, LLC | 43547-639 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | ProPharma Distribution | 84549-543 |