Prescription drug · ANDA
Penicillamine NDC 51991-974
Penicillamine 250 mg/1 · Capsule · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-974-01 | 5199109740151991097401 | 100 CAPSULE in 1 BOTTLE (51991-974-01)Marketed from Nov 12, 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
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215409
- Marketing start
- Listing expires
- Identifiers
- Product ID 51991-974_431fc46e-696d-405a-b2f2-db76282a8907SPL ID 431fc46e-696d-405a-b2f2-db76282a8907SPL set ID 1320f46b-e243-4e93-b9c9-ad8eb7828de5RxCUI 198070UNII GNN1DV99GXUPC 0351991974017
- 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
N451991097401followed by a unit qualifier and the quantityPackage 51991-0974-01. 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 progresse…
Excerpt only. Read the full label for complete information.
About NDC 51991-974
- What is NDC 51991-974?
- 51991-974 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, listed with the FDA by Breckenridge Pharmaceutical, Inc.. 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?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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.
Related NDCs: other Penicillamine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 |