What is NDC 0378-1201?

0378-1201 is the product NDC for Sorafenib Tosylate (sorafenib), Sorafenib tosylate 200 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sorafenib Tosylate (Sorafenib).

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Tosylate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sorafenib Tosylate NDC 0378-1201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1201Add 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
0378-1201-78	0037812017800378120178	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)Marketed from Jun 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Tosylate
Generic name (nonproprietary): sorafenib
Active ingredients: Sorafenib tosylate — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207012
Marketing start: Jun 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Protein Kinase Inhibitors (Mechanism)
Identifiers: Product ID 0378-1201_40e1cce8-b7c1-4fad-8600-7d7b409bde7eSPL ID 40e1cce8-b7c1-4fad-8600-7d7b409bde7eSPL set ID b7919013-1511-44f0-a759-3fa78a9fa178RxCUI 597747UNII 5T62Q3B36J
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

N400378120178 followed by a unit qualifier and the quantity

Package 00378-1201-78. 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 Mar 18, 2026.

Indications (excerpt from the label)

Sorafenib tablets are 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 metasta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1201

What is NDC 0378-1201?: 0378-1201 is the product NDC for Sorafenib Tosylate (sorafenib), Sorafenib tosylate 200 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sorafenib Tosylate (Sorafenib).
What is the active ingredient?: Sorafenib tosylate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Tosylate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Sorafenib Tosylate (Sorafenib) NDC 0378-1201