What is NDC 68475-201?

68475-201 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Penicillamine?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Penicillamine NDC 68475-201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0201Add 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
68475-201-01	6847502010168475020101	100 CAPSULE in 1 BOTTLE (68475-201-01)Marketed from Jan 1, 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): Penicillamine
Generic name (nonproprietary): penicillamine
Active ingredients: Penicillamine — 250 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214363
Marketing start: Jan 1, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4SPL ID 0ee5ea02-a892-408f-aa5d-42ab034bdfc4SPL set ID 064fb48d-aa34-4e52-9295-10f2ca4c77dcRxCUI 198070UNII GNN1DV99GX
Pharmacologic class: Antirheumatic 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 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

N468475020101 followed by a unit qualifier and the quantity

Package 68475-0201-01. 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 Dec 2, 2022.

Indications (excerpt from the label)

INDICATIONS Penicillamine capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. Wilson’s Disease Wilson's disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal-recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. The excess copper is deposited in several organs and tissues, and eventually produces pathological effects primarily in the liver, where damage progresse…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68475-201

What is NDC 68475-201?: 68475-201 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Penicillamine.
What is the active ingredient?: Penicillamine.
Who is the labeler?: Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Penicillamine?: 8 other product NDCs are listed under this name. See all Penicillamine 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 Penicillamine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Breckenridge Pharmaceutical, Inc.	51991-974	51991-0974-01
Penicillamine	Penicillamine 250 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	70748-153	70748-0153-01
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-907	70010-0907-01
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Proficient Rx LP	71205-916	71205-0916-00
Penicillamine	Penicillamine 250 mg/1	Capsule, Gelatin coatedOral	Dr. Reddy's Laboratories Inc.	43598-634	43598-0634-01
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Par Health USA, LLC	49884-146	49884-0146-01
penicillamine	Penicillamine 250 mg/1	Tablet, Film coatedOral	Par Health USA, LLC	0254-2000	00254-2000-01
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Actavis Pharma, Inc.	0591-4171	00591-4171-01