Atropine Sulfate NDC 63323-580

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0580Add 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 NDC	11-digit (billing)	Package	Copy
63323-580-20	63323058020	10 VIAL, MULTI-DOSE in 1 TRAY (63323-580-20) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 23, 2017

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): Atropine Sulfate
Generic name (nonproprietary): atropine sulfate
Active ingredients: Atropine sulfate — .4 mg/mL
Dosage form: Injection, Solution
Route: Endotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209260
Marketing start: Jan 23, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 63323-580_8039a2a4-4c0a-4062-9ca5-78137ba74082SPL ID 8039a2a4-4c0a-4062-9ca5-78137ba74082SPL set ID 310c8a74-ea24-4357-8099-81e394b1634eRxCUI 1190776UNII 03J5ZE7KA5
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

N463323058020 followed by a unit qualifier and the quantity

Package 63323-0580-20. 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 Oct 11, 2024.

Indications (excerpt from the label)

Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life threatening muscarinic effects. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209260

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

FDA NDC Directory listings under NDA 209260
Product	Strength	Form · route	Labeler	Product NDC
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	Henry Schein, Inc.	0404-9804
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	ProPharma Distribution	84549-580
Atropine Sulfate	Atropine sulfate .4 mg/mL	Injection, SolutionEndotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous	REMEDYREPACK INC.	70518-4188