Prescription drug · ANDA
Glycopyrrolate Oral Solution NDC 51672-5316
Glycopyrrolate 1 mg/5mL · Liquid · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-5316-9 | 5167253160951672531609 | 1 BOTTLE in 1 CARTON (51672-5316-9) / 500 mL in 1 BOTTLEMarketed from Jul 5, 2022 |
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 Oral Solution
- Generic name (nonproprietary)
- glycopyrrolate oral solution
- Active ingredients
- Glycopyrrolate — 1 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212467
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 51672-5316_4e7def49-5c38-4c64-e063-6394a90a33c2SPL ID 4e7def49-5c38-4c64-e063-6394a90a33c2SPL set ID e20c9a89-2a81-3c6e-e053-2995a90a9861RxCUI 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
N451672531609followed by a unit qualifier and the quantityPackage 51672-5316-09. 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)
Excerpt only. Read the full label for complete information.
About NDC 51672-5316
- What is NDC 51672-5316?
- 51672-5316 is the product NDC for Glycopyrrolate Oral Solution, Glycopyrrolate 1 mg/5mL liquid, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glycopyrrolate Oral Solution.
- What is the active ingredient?
- Glycopyrrolate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 Oral Solution?
- 2 other product NDCs are listed under this name. See all Glycopyrrolate Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glycopyrrolate Oral Solution 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 Oral Solutionglycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | AJENAT PHARMACEUTICALS LLC | 82983-428 | 82983-0428-47 |
| Glycopyrrolate Oral Solutionglycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | Granules Pharmaceuticals Inc. | 70010-106 | 70010-0106-44 |