Prescription drug · ANDA
glycopyrrolate NDC 69452-406
Glycopyrrolate 1 mg/5mL · Solution · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-406-88 | 6945204068869452040688 | 1 BOTTLE in 1 CARTON (69452-406-88) / 473 mL in 1 BOTTLEMarketed from May 11, 2026 |
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 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220062
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 69452-406_512d3f1e-c35b-87c2-e063-6394a90a8de0SPL ID 512d3f1e-c35b-87c2-e063-6394a90a8de0SPL set ID 512d3f1e-c35c-87c2-e063-6394a90a8de0RxCUI 999961UNII 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
N469452040688followed by a unit qualifier and the quantityPackage 69452-0406-88. 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 oral solution is indicated to reduce chronic severe drooling in patients aged 3 years to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). Glycopyrrolate oral solution is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3 years to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69452-406
- What is NDC 69452-406?
- 69452-406 is the product NDC for glycopyrrolate, Glycopyrrolate 1 mg/5mL solution, listed with the FDA by Bionpharma Inc.. 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?
- Bionpharma Inc., NDC labeler code 69452. 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/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 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9775 | 00404-9775-01 |