NDC codes

FDA NDC Directory
Product NDC (as listed)55111-648Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0648Add 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
55111-648-015511106480155111064801100 TABLET in 1 BOTTLE (55111-648-01)Marketed from Jul 14, 2008
55111-648-055511106480555111064805500 TABLET in 1 BOTTLE (55111-648-05)Marketed from Jul 14, 2008

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/1
Dosage form
Tablet
Route
Oral
Labeler
Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040847
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)
Identifiers
Product ID 55111-648_51baf5c0-1517-06f6-3102-47df40906299SPL ID 51baf5c0-1517-06f6-3102-47df40906299SPL set ID 725529e8-9c4b-4108-690a-e4f391439736RxCUI 197738UNII V92SO9WP2I
Pharmacologic class
Anticholinergic

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

N455111064801 followed by a unit qualifier and the quantity

Package 55111-0648-01. 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)

INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-648

What is NDC 55111-648?
55111-648 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 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?
Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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?
182 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 183 Glycopyrrolate NDCs

Other NDCs under ANDA 040847

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

FDA NDC Directory listings under ANDA 040847
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralDr. Reddy's Laboratories Limited55111-649

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