Prescription drug · ANDA
Glycopyrrolate NDC 0904-6709
Glycopyrrolate 1 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6709-61 | 00904670961 | 100 BLISTER PACK in 1 CARTON (0904-6709-61) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 27, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- 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 0904-6709_ebc35f92-eb12-412f-93e8-ff7a9a1f73fdSPL ID ebc35f92-eb12-412f-93e8-ff7a9a1f73fdSPL set ID 6e5bfe6d-d321-4f0f-86e2-457d8fd10a6aRxCUI 197738UNII 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
N400904670961followed by a unit qualifier and the quantityPackage 00904-6709-61. 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 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-734 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Chartwell RX, LLC | 62135-735 |
| 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 |