What is NDC 65857-200?

65857-200 is the product NDC for Ammonia N-13, Ammonia n-13 37.5 mCi/mL injection, listed with the FDA by Cardinal Health 414, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Cardinal Health 414, LLC, NDC labeler code 65857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ammonia N-13?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ammonia N-13 NDC 65857-200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65857-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65857-0200Add 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
65857-200-10	6585702001065857020010	10 mL in 1 VIAL, GLASS (65857-200-10)Marketed from Feb 25, 2013

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): Ammonia N-13Suffix: N-13
Generic name (nonproprietary): ammonia n-13
Active ingredients: Ammonia n-13 — 37.5 mCi/mL
Dosage form: Injection
Route: Intravenous
Labeler: Cardinal Health 414, LLCNDC labeler code 65857
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203700
Marketing start: Feb 25, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Radiopharmaceutical Activity (Mechanism)
Identifiers: Product ID 65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02SPL ID 886dbcba-5cf9-4d8b-95c0-d4fc574e8e02SPL set ID 4c563174-c7cd-4224-b865-4da2f39c21c0UNII 9OQO0E343Z
Pharmacologic class: Radioactive Diagnostic Agent

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

N465857020010 followed by a unit qualifier and the quantity

Package 65857-0200-10. 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 Jul 11, 2018.

Indications (excerpt from the label)

Ammonia N-13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N-13 Injection, USP is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65857-200

What is NDC 65857-200?: 65857-200 is the product NDC for Ammonia N-13, Ammonia n-13 37.5 mCi/mL injection, listed with the FDA by Cardinal Health 414, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ammonia N-13.
What is the active ingredient?: Ammonia n-13.
Who is the labeler?: Cardinal Health 414, LLC, NDC labeler code 65857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ammonia N-13?: 18 other product NDCs are listed under this name. See all Ammonia N-13 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 Ammonia N-13 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ammonia N-13	Ammonia n-13 260 mCi/mL	InjectionIntravenous	The Methodist Hospital Research Institute	69864-002	69864-0002-30
Ammonia N 13	Ammonia n-13 37.5 mCi/mL	InjectionIntravenous	University of Wisconsin System	72333-001	72333-0001-10
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	Injection, SolutionIntravenous	The University of Texas Southwestern Medical Center	70681-001	70681-0001-30
Ammonia N 13	Ammonia n-13 37.5 mCi/mL	InjectionIntravenous	SOFIE Co. dba SOFIE	73410-001	73410-0001-01
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	InjectionIntravenous	Ionetix Corporation	71162-001	71162-0001-05
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	Injection, SolutionIntravenous	Massachusetts General Hospital	76318-643	76318-0643-30
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	Injection, SolutionIntravenous	Biomedical Research Foundation of Northwest Louisiana	24562-004	24562-0004-30
Ammonia N-13	Ammonia n-13 37.5 mCi/mL	InjectionIntravenous	Brigham and Women's Hospital, Inc., The	24450-113	24450-0113-10
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	InjectionIntravenous	Kreitchman PET Center	62072-456	62072-0456-56
Ammonia N 13ammonia n-13	Ammonia n-13 37.5 mCi/mL	Injection, SolutionIntravenous	Mayo Clinic	52670-552	52670-0552-30

All 19 Ammonia N-13 NDCs