NDC codes

FDA NDC Directory
Product NDC (as listed)49884-042Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0042Add 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
49884-042-33498840042334988400423316 mL in 1 BOTTLE (49884-042-33)Marketed from Jan 4, 2022

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
Par Health USA, LLCNDC labeler code 49884
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204438
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 49884-042_3492c9f9-7d9b-4943-a68c-5e269f056640SPL ID 3492c9f9-7d9b-4943-a68c-5e269f056640SPL set ID ff65c5d3-7ba9-4315-a884-199151eb45a5RxCUI 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

N449884004233 followed by a unit qualifier and the quantity

Package 49884-0042-33. 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 to16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49884-042

What is NDC 49884-042?
49884-042 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/5mL solution, listed with the FDA by Par Health USA, 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?
Par Health USA, LLC, NDC labeler code 49884. 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.

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

Other Glycopyrrolate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GlycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralQUAGEN PHARMACEUTICALS LLC70752-17570752-0175-12
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralREMEDYREPACK INC.70518-467170518-4671-00
glycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralBionpharma Inc.69452-40669452-0406-88
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralREMEDYREPACK INC.70518-459770518-4597-00
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-11071921-0110-01
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-11171921-0111-01
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousJvet Pharmaceuticals LLC86211-11386211-0113-10
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralREMEDYREPACK INC.70518-453770518-4537-00
GlycopyrrolateGlycopyrrolate .2 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-977600404-9776-05
GlycopyrrolateGlycopyrrolate .2 mg/mLInjection, SolutionIntramuscular, IntravenousHenry Schein, Inc.0404-977700404-9777-20

All 180 Glycopyrrolate NDCs

Other NDCs under ANDA 204438

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204438
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralBryant Ranch Prepack63629-9592
GlycopyrrolateGlycopyrrolate 1 mg/5mLSolutionOralPrecision Dose, Inc.68094-073

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