What is NDC 71863-120?

71863-120 is the product NDC for Nitisinone, Nitisinone 5 mg/1 capsule, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nitisinone?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitisinone NDC 71863-120 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71863-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71863-0120Add 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
71863-120-60	7186301206071863012060	1 BOTTLE in 1 CARTON (71863-120-60) / 60 CAPSULE in 1 BOTTLEMarketed from Jan 15, 2024

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): Nitisinone
Generic name (nonproprietary): nitisinone
Active ingredients: Nitisinone — 5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Eton Pharmaceuticals, Inc.NDC labeler code 71863
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216201
Marketing start: Jan 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2E1 Inducers (Mechanism)Hydroxyphenylpyruvate Dioxygenase Inhibitors (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)
Identifiers: Product ID 71863-120_42c7c79b-1aa1-12bc-e063-6394a90a5ff8SPL ID 42c7c79b-1aa1-12bc-e063-6394a90a5ff8SPL set ID dc5e4875-fcd7-408c-88c9-4a715f4384b6RxCUI 351173, 351174, 351175, 1798999UNII K5BN214699UPC 0371863119605, 0371863120601, 0371863122605
Pharmacologic class: 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor

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

N471863012060 followed by a unit qualifier and the quantity

Package 71863-0120-60. 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 Feb 2, 2024.

Indications (excerpt from the label)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE Capsules, for oral use Initial U.S. Approval: 2002 1. INDICATIONS AND USAGE Nitisinone Capsules is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyros…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71863-120

What is NDC 71863-120?: 71863-120 is the product NDC for Nitisinone, Nitisinone 5 mg/1 capsule, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nitisinone.
What is the active ingredient?: Nitisinone.
Who is the labeler?: Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nitisinone?: 13 other product NDCs are listed under this name. See all Nitisinone 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 Nitisinone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nitisinone	Nitisinone 2 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-119	71863-0119-60
Nitisinone	Nitisinone 10 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-121	71863-0121-60
Nitisinone	Nitisinone 20 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-122	71863-0122-60
Nitisinone	Nitisinone 20 mg/1	CapsuleOral	Analog Pharma	70505-220	70505-0220-60
Nitisinone	Nitisinone 2 mg/1	CapsuleOral	Analog Pharma	70505-202	70505-0202-60
Nitisinone	Nitisinone 5 mg/1	CapsuleOral	Analog Pharma	70505-205	70505-0205-60
Nitisinone	Nitisinone 10 mg/1	CapsuleOral	Analog Pharma	70505-210	70505-0210-60
Nitisinone	Nitisinone 2 mg/1	CapsuleOral	Par Health USA, LLC	0254-3020	00254-3020-02
Nitisinone	Nitisinone 5 mg/1	CapsuleOral	Par Health USA, LLC	0254-3021	00254-3021-02
Nitisinone	Nitisinone 10 mg/1	CapsuleOral	Par Health USA, LLC	0254-3022	00254-3022-02

All 14 Nitisinone NDCs

Other NDCs under ANDA 216201

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

FDA NDC Directory listings under ANDA 216201
Product	Strength	Form · route	Labeler	Product NDC
Nitisinone	Nitisinone 2 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-119
Nitisinone	Nitisinone 10 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-121
Nitisinone	Nitisinone 20 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-122