Prescription drug · ANDA
Glycopyrrolate NDC 49884-066
Glycopyrrolate 2 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-066-01 | 49884006601 | 100 TABLET in 1 BOTTLE (49884-066-01)Marketed from Sep 26, 2006 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040653
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 49884-066_3b3e28e1-8b2f-4947-8ca3-41b53aeade8eSPL ID 3b3e28e1-8b2f-4947-8ca3-41b53aeade8eSPL set ID 1f266d77-4f9e-44c9-a000-2f8fea3ac80bRxCUI 197738, 197739UNII V92SO9WP2IUPC 0349884065010, 0349884066017
- 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
N449884006601followed by a unit qualifier and the quantityPackage 49884-0066-01. 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)
Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate tablets are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040653
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 | Par Health USA, LLC | 49884-065 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2206 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2207 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2119 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1477 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1478 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9287 |