What is NDC 13668-682?

13668-682 is the product NDC for Sorafenib, Sorafenib 200 mg/1 tablet, film coated, listed with the FDA by Torrent Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 13668-682 | National Drug Code

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 NDC	11-digit (billing)	Package
13668-682-12	1366806821213668068212	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12)Marketed from Apr 12, 2023
13668-682-30	1366806823013668068230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30)Marketed from Apr 12, 2023
13668-682-60	1366806826013668068260	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)Marketed from Apr 12, 2023
13668-682-74	1366806827413668068274	10 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
Labeler: Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217095
Marketing start: Apr 12, 2023
Listing expires: Dec 31, 2027
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 Feb 11, 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 13668-682

What is NDC 13668-682?: 13668-682 is the product NDC for Sorafenib, Sorafenib 200 mg/1 tablet, film coated, listed with the FDA by Torrent Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sorafenib.
What is the active ingredient?: Sorafenib.
Who is the labeler?: Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 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
sorafenib	Sorafenib tosylate 200 mg/1	Tablet, Film coatedOral	Dr.Reddys Laboratories Inc	43598-458	43598-0458-0443598-0458-36