Prescription drug · ANDA
Glycopyrrolate NDC 13107-015
Glycopyrrolate 2 mg/1 · Tablet · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-015-01 | 1310700150113107001501 | 100 TABLET in 1 BOTTLE (13107-015-01)Marketed from Feb 28, 2023 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202675
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 13107-015_1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448SPL ID 1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448SPL set ID 677f8495-a870-45b6-bb65-75b449f040ceRxCUI 197738, 197739UNII V92SO9WP2IUPC 0313107014017
- 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
N413107001501followed by a unit qualifier and the quantityPackage 13107-0015-01. 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.
About NDC 13107-015
- What is NDC 13107-015?
- 13107-015 is the product NDC for Glycopyrrolate, Glycopyrrolate 2 mg/1 tablet, listed with the FDA by Aurolife 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?
- Aurolife Pharma LLC, NDC labeler code 13107. 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?
- 179 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 202675
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8617 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-014 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | AvPAK | 50268-363 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | American Health Packaging | 60687-458 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7207 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4671 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2720 |