Prescription drug · ANDA
Glycopyrrolate NDC 70518-4537
Glycopyrrolate 2 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4537-0 | 70518453700 | 100 POUCH in 1 BOX (70518-4537-0) / 1 TABLET in 1 POUCH (70518-4537-1)Marketed from Dec 17, 2025 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212696
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4537_5b9bdb65-2322-b56c-e063-6394a90a4c28SPL ID 5b9bdb65-2322-b56c-e063-6394a90a4c28
- 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 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
N470518453700followed by a unit qualifier and the quantityPackage 70518-4537-00. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 212696
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 1 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-108 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-109 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2597 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2598 |