NDC codes

FDA NDC Directory
Product NDC (as listed)51672-5316Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-5316Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51672-5316-951672531609516725316091 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

N451672531609 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Glycopyrrolate Oral Solution NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Glycopyrrolate Oral SolutionglycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralAJENAT PHARMACEUTICALS LLC82983-42882983-0428-47
Glycopyrrolate Oral SolutionglycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralGranules Pharmaceuticals Inc.70010-10670010-0106-44

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