Prescription drug · ANDA
Penicillamine NDC 71205-916
Penicillamine 250 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-916-00 | 71205091600 | 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 LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211735
- Marketing start
- Listing expires
- 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
N471205091600followed by a unit qualifier and the quantityPackage 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 . 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.
Other NDCs under ANDA 211735
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Penicillamine | Penicillamine 250 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc. | 70010-907 |