Prescription drug · ANDA
Glycopyrrolate NDC 72887-160
Glycopyrrolate 1.5 mg/1 · Tablet · Oral · FH2 Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72887-160-03 | 72887016003 | 30 TABLET in 1 BOTTLE (72887-160-03)Marketed from Nov 29, 2021 |
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 — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- FH2 Pharma LLCNDC labeler code 72887
- 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 72887-160_5bc26249-4e9b-4870-a696-99779c90dc27SPL ID 5bc26249-4e9b-4870-a696-99779c90dc27SPL set ID 18ca98ed-522d-470f-bb22-908bbd7d489aRxCUI 1247658UNII 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
N472887016003followed by a unit qualifier and the quantityPackage 72887-0160-03. 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 72887-160
- What is NDC 72887-160?
- 72887-160 is the product NDC for Glycopyrrolate, Glycopyrrolate 1.5 mg/1 tablet, listed with the FDA by FH2 Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glycopyrrolate.
- What is the active ingredient?
- Glycopyrrolate.
- Who is the labeler?
- FH2 Pharma LLC, NDC labeler code 72887. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glycopyrrolate?
- 182 other product NDCs are listed under this name. See all Glycopyrrolate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glycopyrrolate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-175 | 70752-0175-12 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4671 | 70518-4671-00 |
| glycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | Bionpharma Inc. | 69452-406 | 69452-0406-88 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4597 | 70518-4597-00 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-110 | 71921-0110-01 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-111 | 71921-0111-01 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Jvet Pharmaceuticals LLC | 86211-113 | 86211-0113-10 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4537 | 70518-4537-00 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9776 | 00404-9776-05 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9777 | 00404-9777-20 |
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 |
|---|---|---|---|---|
| Glycateglycopyrrolate | Glycopyrrolate 1.5 mg/1 | TabletOral | Intra-Sana Laboratories | 80056-160 |
| Glycopyrrolate | Glycopyrrolate 1.5 mg/1 | TabletOral | LGM PHARMA SOLUTIONS, LLC | 79739-7097 |