Prescription drug · ANDA
Glycate (Glycopyrrolate) NDC 80056-160
Glycopyrrolate 1.5 mg/1 · Tablet · Oral · Intra-Sana Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80056-160-10 | 8005601601080056016010 | 100 TABLET in 1 BOTTLE (80056-160-10)Marketed from Apr 1, 2022 |
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)
- Glycate
- Generic name (nonproprietary)
- glycopyrrolate
- Active ingredients
- Glycopyrrolate — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Intra-Sana LaboratoriesNDC labeler code 80056
- 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)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 80056-160_feae0733-6244-4791-b717-581bde769f02SPL ID feae0733-6244-4791-b717-581bde769f02SPL set ID 830ba1be-bef3-417c-a915-964cc6005b92RxCUI 1247658, 1437975UNII V92SO9WP2I
- 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
N480056016010followed by a unit qualifier and the quantityPackage 80056-0160-10. 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.
About NDC 80056-160
- What is NDC 80056-160?
- 80056-160 is the product NDC for Glycate (glycopyrrolate), Glycopyrrolate 1.5 mg/1 tablet, listed with the FDA by Intra-Sana Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glycate (Glycopyrrolate).
- What is the active ingredient?
- Glycopyrrolate.
- Who is the labeler?
- Intra-Sana Laboratories, NDC labeler code 80056. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glycate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Glycopyrrolate | Glycopyrrolate 1.5 mg/1 | TabletOral | LGM PHARMA SOLUTIONS, LLC | 79739-7097 |