NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7207Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7207Add 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
63629-7207-1636297207016362972070130 TABLET in 1 BOTTLE (63629-7207-1)Marketed from Feb 18, 2021
63629-7207-26362972070263629720702270 TABLET in 1 BOTTLE (63629-7207-2)Marketed from Mar 2, 2017
63629-7207-3636297207036362972070328 TABLET in 1 BOTTLE (63629-7207-3)Marketed from Sep 5, 2024
63629-7207-4636297207046362972070490 TABLET in 1 BOTTLE (63629-7207-4)Marketed from Dec 15, 2017
63629-7207-56362972070563629720705100 TABLET in 1 BOTTLE (63629-7207-5)Marketed from Sep 5, 2024

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
Generic name (nonproprietary)
glycopyrrolate
Active ingredients
Glycopyrrolate — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202675
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 63629-7207_231a1231-822a-443b-a8f1-fba28fe3d64cSPL ID 231a1231-822a-443b-a8f1-fba28fe3d64cSPL set ID 21c7d201-c0b8-4f16-be4a-681d0b22791eRxCUI 197738UNII 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

N463629720701 followed by a unit qualifier and the quantity

Package 63629-7207-01. 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 tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate tablets are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. ( 1 ) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-7207

What is NDC 63629-7207?
63629-7207 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 202675

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

FDA NDC Directory listings under ANDA 202675
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8617
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralAurolife Pharma LLC13107-014
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralAurolife Pharma LLC13107-015
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralAvPAK50268-363
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralAmerican Health Packaging60687-458
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralREMEDYREPACK INC.70518-4671
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralBryant Ranch Prepack71335-2720

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