Prescription drug · ANDA
Penicillamine NDC 49884-146
Penicillamine 250 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-146-01 | 49884014601 | 100 CAPSULE in 1 BOTTLE (49884-146-01)Marketed from Jan 8, 2020 |
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
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211231
- Marketing start
- Listing expires
- Identifiers
- Product ID 49884-146_3ffa8233-d878-41c1-9da7-7c8ed676b447SPL ID 3ffa8233-d878-41c1-9da7-7c8ed676b447SPL set ID 01e79d8f-8c74-4f48-b761-9f225fabf93dRxCUI 198070UNII GNN1DV99GXUPC 0349884146016
- 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
N449884014601followed by a unit qualifier and the quantityPackage 49884-0146-01. 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 . 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. W il son’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 progr…
Excerpt only. Read the full label for complete information.