Prescription drug · ANDA
Glycopyrrolate NDC 62135-734
Glycopyrrolate 1 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-734-60 | 62135073460 | 60 TABLET in 1 BOTTLE (62135-734-60)Marketed from Aug 15, 2023 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207201
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 62135-734_459bf618-08fb-b182-e063-6394a90a48dcSPL ID 459bf618-08fb-b182-e063-6394a90a48dcSPL set ID 5773cf63-4006-4d8f-b53b-c84bcfe19e4aRxCUI 197738, 197739UNII V92SO9WP2IUPC 0362135734602, 0362135735609
- 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
N462135073460followed by a unit qualifier and the quantityPackage 62135-0734-60. 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 is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate is 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 207201
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 | Chartwell RX, LLC | 62135-735 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6709 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3031 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2075 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-607 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-606 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4597 |