Prescription drug · ANDA
Penicillamine NDC 43598-634
Penicillamine 250 mg/1 · Capsule, Gelatin coated · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-634-01 | 43598063401 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43598-634-01)Marketed from Aug 4, 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, Gelatin coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211867
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-634_95e0de3d-c587-1569-8808-6c419f7208ecSPL ID 95e0de3d-c587-1569-8808-6c419f7208ecSPL set ID 15d08594-83a9-cc7a-92ef-1bac0427e121RxCUI 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
N443598063401followed by a unit qualifier and the quantityPackage 43598-0634-01. 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. 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.