What is NDC 59651-435?

59651-435 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/5mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glycopyrrolate NDC 59651-435 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0435Add 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 NDC	11-digit (billing)	Package	Copy
59651-435-47	59651043547	1 BOTTLE in 1 CARTON (59651-435-47) / 473 mL in 1 BOTTLEMarketed from Dec 31, 2024

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: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214847
Marketing start: Dec 31, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 59651-435_f7f77262-6bba-489e-872c-3cd4266681b6SPL ID f7f77262-6bba-489e-872c-3cd4266681b6SPL set ID 4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b8RxCUI 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

N459651043547 followed by a unit qualifier and the quantity

Package 59651-0435-47. 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 Apr 17, 2025.

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 is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3 to 16 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 59651-435

What is NDC 59651-435?: 59651-435 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/5mL solution, listed with the FDA by Aurobindo Pharma Limited. 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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
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/5mL	SolutionOral	Bionpharma Inc.	69452-406	69452-0406-88
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

All 180 Glycopyrrolate NDCs