Prescription drug · ANDA
Glycopyrrolate NDC 79739-7097
Glycopyrrolate 1.5 mg/1 · Tablet · Oral · LGM PHARMA SOLUTIONS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79739-7097-1 | 79739709701 | 100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1)Marketed from Mar 12, 2012 |
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 — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- LGM PHARMA SOLUTIONS, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091522
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 79739-7097_9004cf80-5ded-482e-89ca-841fcd89f778SPL ID 9004cf80-5ded-482e-89ca-841fcd89f778SPL set ID 392a969d-1e14-4ad8-835c-a47be4983067RxCUI 1247658UNII V92SO9WP2IUPC 0379739709714
- 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
N479739709701followed by a unit qualifier and the quantityPackage 79739-7097-01. 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 091522
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 1.5 mg/1 | TabletOral | FH2 Pharma LLC | 72887-160 |
| Glycateglycopyrrolate | Glycopyrrolate 1.5 mg/1 | TabletOral | Intra-Sana Laboratories | 80056-160 |