NDC codes

FDA NDC Directory
Product NDC (as listed)13668-682Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0682Add 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 NDC11-digit (billing)PackageCopy
13668-682-1213668068212120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12)Marketed from Apr 12, 2023
13668-682-301366806823030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30)Marketed from Apr 12, 2023
13668-682-601366806826060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)Marketed from Apr 12, 2023
13668-682-741366806827410 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2023

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 — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217095
Marketing start
Listing expires
Other FDA classes
Protein Kinase Inhibitors (Mechanism)
Identifiers
Product ID 13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20SPL ID 27389dc4-60cc-4c65-92e6-97bcc09f7d20SPL set ID b5305e23-7bc6-44d8-b177-930c47d1653aRxCUI 597747UNII 9ZOQ3TZI87UPC 0313668682304
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

N413668068212 followed by a unit qualifier and the quantity

Package 13668-0682-12. 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 .

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)

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