What is NDC 70505-202?

70505-202 is the product NDC for Nitisinone, Nitisinone 2 mg/1 capsule, listed with the FDA by Analog Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

Analog Pharma, NDC labeler code 70505. 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 70505-202 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70505-202Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70505-0202Add 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
70505-202-60	7050502026070505020260	1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTICMarketed from Jun 15, 2022

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 — 2 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Analog PharmaNDC labeler code 70505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212390
Marketing start: Jun 15, 2022
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 70505-202_f74e0d5c-aaae-4751-a24d-4d141dfcae61SPL ID f74e0d5c-aaae-4751-a24d-4d141dfcae61SPL set ID 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0RxCUI 351173, 351174, 351175, 1798999UNII K5BN214699
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

N470505020260 followed by a unit qualifier and the quantity

Package 70505-0202-60. 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 Sep 5, 2025.

Indications (excerpt from the label)

Nitisinone capsules are 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 capsules are 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 tyrosine and phenylalanine. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70505-202

What is NDC 70505-202?: 70505-202 is the product NDC for Nitisinone, Nitisinone 2 mg/1 capsule, listed with the FDA by Analog Pharma. 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?: Analog Pharma, NDC labeler code 70505. 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 5 mg/1	CapsuleOral	Eton Pharmaceuticals, Inc.	71863-120	71863-0120-60
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 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 212390

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

FDA NDC Directory listings under ANDA 212390
Product	Strength	Form · route	Labeler	Product NDC
Nitisinone	Nitisinone 5 mg/1	CapsuleOral	Analog Pharma	70505-205
Nitisinone	Nitisinone 10 mg/1	CapsuleOral	Analog Pharma	70505-210
Nitisinone	Nitisinone 20 mg/1	CapsuleOral	Analog Pharma	70505-220