What is NDC 71205-916?

71205-916 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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 71205-916 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-916Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0916Add 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
71205-916-00	7120509160071205091600	100 CAPSULE in 1 BOTTLE (71205-916-00)Marketed from Jul 8, 2021

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: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211735
Marketing start: Dec 21, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 71205-916_125ca13e-9784-45be-847a-6fdf9875bd6aSPL ID 125ca13e-9784-45be-847a-6fdf9875bd6aSPL set ID c92335c6-f6fa-4768-9401-55c6b7f87699RxCUI 198070UNII GNN1DV99GXUPC 0371205916008
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

N471205091600 followed by a unit qualifier and the quantity

Package 71205-0916-00. 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 Apr 1, 2022. This label includes a boxed warning.

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 progres…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-916

What is NDC 71205-916?: 71205-916 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 71205. 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	Navinta LLC	68475-201	68475-0201-01
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	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

Other NDCs under ANDA 211735

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

FDA NDC Directory listings under ANDA 211735
Product	Strength	Form · route	Labeler	Product NDC
Penicillamine	Penicillamine 250 mg/1	CapsuleOral	Granules Pharmaceuticals Inc.	70010-907