NDC codes

FDA NDC Directory
Product NDC (as listed)43547-639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0639Add 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
43547-639-25435470639254354706392525 VIAL, SINGLE-DOSE in 1 CARTON (43547-639-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43547-639-01)Marketed from May 1, 2021

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 — .2 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
Solco Healthcare US, LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210927
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 43547-639_8a403c54-3e23-41fc-bf80-c40e8d867aa2SPL ID 8a403c54-3e23-41fc-bf80-c40e8d867aa2SPL set ID 2972f22e-378c-450b-8869-1354a9bd0ffcRxCUI 1731582, 1731590UNII V92SO9WP2IUPC 0343547639013, 0343547640019
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N443547063925 followed by a unit qualifier and the quantity

Package 43547-0639-25. 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 injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) • for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation. • intraoperatively to counteract surgically or drug-induced or vagal reflex- associated arrhythmias. • for protection against peripheral muscarinic effects of cholinergic agents. ( 1 ) in peptic ulcer (adults) • To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated. Lim…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-639

What is NDC 43547-639?
43547-639 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, listed with the FDA by Solco Healthcare US, 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?
Solco Healthcare US, LLC, NDC labeler code 43547. 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 210927

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

FDA NDC Directory listings under ANDA 210927
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousSolco Healthcare US, LLC43547-543
GlycopyrrolateGlycopyrrolate .4 mg/2mLInjectionIntramuscular, IntravenousSolco Healthcare US, LLC43547-544
GlycopyrrolateGlycopyrrolate .4 mg/2mLInjectionIntramuscular, IntravenousSolco Healthcare US, LLC43547-640
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7208
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousProPharma Distribution84549-543

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in