Prescription drug · ANDA
Glycopyrrolate Oral Solution (glycopyrrolate) NDC 82983-428
Glycopyrrolate 1 mg/5mL · Solution · Oral · AJENAT PHARMACEUTICALS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82983-428-47 | 82983042847 | 1 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLEMarketed from Dec 12, 2025 |
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 Oral Solution
- Generic name (nonproprietary)
- glycopyrrolate
- Active ingredients
- Glycopyrrolate — 1 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- AJENAT PHARMACEUTICALS LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219267
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79SPL ID 80036e14-8ef8-4d3e-a6c5-4bfca592dd79SPL set ID 7049feaf-004a-481f-b129-996b21c3170aRxCUI 999961UNII V92SO9WP2IUPC 0382983428478
- 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
N482983042847followed by a unit qualifier and the quantityPackage 82983-0428-47. 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 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 3-16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). ( 1 )
Excerpt only. Read the full label for complete information.