What is NDC 43598-634?

43598-634 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, gelatin coated, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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 43598-634 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0634Add 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
43598-634-01	4359806340143598063401	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
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211867
Marketing start: Aug 4, 2020
Listing expires: Dec 31, 2027
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

N443598063401 followed by a unit qualifier and the quantity

Package 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 Aug 5, 2020. 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 43598-634

What is NDC 43598-634?: 43598-634 is the product NDC for Penicillamine, Penicillamine 250 mg/1 capsule, gelatin coated, listed with the FDA by Dr. Reddy's Laboratories 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?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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	CapsuleOral	Proficient Rx LP	71205-916	71205-0916-00
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