NDC codes

FDA NDC Directory
Product NDC (as listed)16729-473Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0473Add 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
16729-473-031672904730310 VIAL, MULTI-DOSE in 1 CARTON (16729-473-03) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 17, 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 — .2 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
Accord Healthcare, Inc.,NDC labeler code 16729
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213238
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 16729-473_415de5a5-d773-4816-e063-6294a90a6853SPL ID 415de5a5-d773-4816-e063-6294a90a6853SPL set ID 871797f0-697a-4a29-a37b-d06219e8f266RxCUI 238212, 1731582, 1731590UNII V92SO9WP2IUPC 0316729474054, 0316729472302, 0316729473316, 0316729471633
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

N416729047303 followed by a unit qualifier and the quantity

Package 16729-0473-03. 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)

INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular block…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-473

What is NDC 16729-473?
16729-473 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, listed with the FDA by Accord Healthcare, Inc.,. 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?
Accord Healthcare, Inc.,, NDC labeler code 16729. 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 2 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-11171921-0111-01
GlycopyrrolateGlycopyrrolate 1 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-11071921-0110-01
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 213238

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

FDA NDC Directory listings under ANDA 213238
ProductStrengthForm · routeLabelerProduct NDC
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousAccord Healthcare, Inc.,16729-471
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousAccord Healthcare, Inc.,16729-474
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousAccord Healthcare, Inc.,16729-472
GlycopyrrolateGlycopyrrolate .2 mg/mLInjectionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7238

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