Prescription drug · ANDA
Glycopyrrolate NDC 71335-1225
Glycopyrrolate 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1225-1 | 71335122501 | 30 TABLET in 1 BOTTLE (71335-1225-1)Marketed from Dec 28, 2021 | |
| 71335-1225-2 | 71335122502 | 90 TABLET in 1 BOTTLE (71335-1225-2)Marketed from Dec 28, 2021 | |
| 71335-1225-3 | 71335122503 | 28 TABLET in 1 BOTTLE (71335-1225-3)Marketed from Dec 28, 2021 | |
| 71335-1225-4 | 71335122504 | 18 TABLET in 1 BOTTLE (71335-1225-4)Marketed from Dec 28, 2021 |
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)
- Glycopyrrolate
- Generic name (nonproprietary)
- glycopyrrolate
- Active ingredients
- Glycopyrrolate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091182
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1225_fd7e1dca-5b7e-37d5-e053-6394a90a5c9bSPL ID fd7e1dca-5b7e-37d5-e053-6394a90a5c9bSPL set ID 4c733750-45fe-4876-8e4f-c61c52470405RxCUI 197739UNII V92SO9WP2I
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335122501followed by a unit qualifier and the quantityPackage 71335-1225-01. 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 For use as adjunctive therapy in the treatment of peptic ulcer.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091182
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/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-666 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-110 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-111 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Quinn Pharmaceuticals | 69076-475 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Quinn Pharmaceuticals | 69076-476 |