Prescription drug · ANDA
Glycopyrrolate NDC 71335-9652
Glycopyrrolate 1 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9652-1 | 71335965201 | 30 TABLET in 1 BOTTLE (71335-9652-1)Marketed from Dec 12, 2024 | |
| 71335-9652-2 | 71335965202 | 270 TABLET in 1 BOTTLE (71335-9652-2)Marketed from Dec 12, 2024 | |
| 71335-9652-3 | 71335965203 | 28 TABLET in 1 BOTTLE (71335-9652-3)Marketed from Dec 12, 2024 | |
| 71335-9652-4 | 71335965204 | 90 TABLET in 1 BOTTLE (71335-9652-4)Marketed from Dec 12, 2024 | |
| 71335-9652-5 | 71335965205 | 100 TABLET in 1 BOTTLE (71335-9652-5)Marketed from Apr 1, 2024 |
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 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090195
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 71335-9652_4315b975-431b-4a6a-8224-04e767e6658dSPL ID 4315b975-431b-4a6a-8224-04e767e6658dSPL set ID 5ee5f433-fd99-4c8d-8263-b8956d489620RxCUI 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
N471335965201followed by a unit qualifier and the quantityPackage 71335-9652-01. 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)
Glycopyrrolate Tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate Tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate tablets are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090195
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 | Leading Pharma, LLC | 69315-139 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Leading Pharma, LLC | 69315-140 |