NDC codes

FDA NDC Directory
Product NDC (as listed)16571-743Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0743Add 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
16571-743-03165710743031657107430330 TABLET in 1 CONTAINER (16571-743-03)Marketed from Oct 6, 2020
16571-743-09165710743091657107430990 TABLET in 1 CONTAINER (16571-743-09)Marketed from Oct 6, 2020

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
Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 012827
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 16571-743_9f8d9c4c-f326-4784-8ea4-f791613077f7SPL ID 9f8d9c4c-f326-4784-8ea4-f791613077f7SPL set ID 58c4cb1f-59b8-4be9-a222-2264ca077d93RxCUI 197738, 197739UNII V92SO9WP2IUPC 0316571743094
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

N416571074303 followed by a unit qualifier and the quantity

Package 16571-0743-03. 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 are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. Glycopyrrolate 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 16571-743

What is NDC 16571-743?
16571-743 is the product NDC for Glycopyrrolate, Glycopyrrolate 1 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. 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?
Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 NDA 012827

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

FDA NDC Directory listings under NDA 012827
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate 2 mg/1TabletOralRising Pharma Holdings, Inc.16571-744
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralBryant Ranch Prepack71335-3090

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