What is NDC 43598-458?

43598-458 is the product NDC for sorafenib, Sorafenib tosylate 200 mg/1 tablet, film coated, listed with the FDA by Dr.Reddys Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr.Reddys 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 sorafenib?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

sorafenib NDC 43598-458 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-458Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0458Add 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
43598-458-04	4359804580443598045804	120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04)Marketed from Jun 8, 2022
43598-458-36	4359804583643598045836	360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36)Marketed from Jun 8, 2022

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): sorafenib
Generic name (nonproprietary): sorafenib
Active ingredients: Sorafenib tosylate — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr.Reddys Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216073
Marketing start: Jun 8, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 43598-458_b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925SPL ID b89d7cf3-c673-51c1-7ceb-9ce1cc1ad925SPL set ID 93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6RxCUI 597747UNII 5T62Q3B36JUPC 0343598458045
Pharmacologic class: Kinase Inhibitor

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

N443598045804 followed by a unit qualifier and the quantity

Package 43598-0458-04. 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 Dec 2, 2024.

Indications (excerpt from the label)

Sorafenib is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, prog…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-458

What is NDC 43598-458?: 43598-458 is the product NDC for sorafenib, Sorafenib tosylate 200 mg/1 tablet, film coated, listed with the FDA by Dr.Reddys Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: sorafenib.
What is the active ingredient?: Sorafenib tosylate.
Who is the labeler?: Dr.Reddys 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 sorafenib?: 5 other product NDCs are listed under this name. See all sorafenib 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 sorafenib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sorafenib	Sorafenib 200 mg/1	Tablet, Film coatedOral	Torrent Pharmaceuticals Limited	13668-682	13668-0682-1213668-0682-3013668-0682-60+1 more
Sorafenib	Sorafenib tosylate 200 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-5425	00480-5425-89
sorafenib	Sorafenib 200 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	24979-715	24979-0715-0424979-0715-44
sorafenib	Sorafenib 200 mg/1	Tablet, Film coatedOral	Yabao Pharmaceutical Co., Ltd. Beijing	51990-201	51990-0201-0651990-0201-12
sorafenib	Sorafenib 200 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-760	51407-0760-12