NDC codes

FDA NDC Directory
Product NDC (as listed)51990-201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51990-0201Add 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
51990-201-06519900201065199002010660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06)Marketed from Dec 1, 2022
51990-201-125199002011251990020112120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12)Marketed from Dec 1, 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 — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Yabao Pharmaceutical Co., Ltd. BeijingNDC labeler code 51990
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209050
Marketing start
Listing expires
Other FDA classes
Protein Kinase Inhibitors (Mechanism)
Identifiers
Product ID 51990-201_533bf507-3ac8-7c25-e063-6294a90a7ff2SPL ID 533bf507-3ac8-7c25-e063-6294a90a7ff2SPL set ID 06f442d6-071e-4081-b7f7-40f3b803ab3fRxCUI 597747UNII 9ZOQ3TZI87
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

N451990020106 followed by a unit qualifier and the quantity

Package 51990-0201-06. 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) 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). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51990-201

What is NDC 51990-201?
51990-201 is the product NDC for sorafenib, Sorafenib 200 mg/1 tablet, film coated, listed with the FDA by Yabao Pharmaceutical Co., Ltd. Beijing. 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.
Who is the labeler?
Yabao Pharmaceutical Co., Ltd. Beijing, NDC labeler code 51990. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SorafenibSorafenib 200 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-68213668-0682-1213668-0682-3013668-0682-60+1 more
SorafenibSorafenib tosylate 200 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-542500480-5425-89
sorafenibSorafenib 200 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-71524979-0715-0424979-0715-44
sorafenibSorafenib 200 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-76051407-0760-12
sorafenibSorafenib tosylate 200 mg/1Tablet, Film coatedOralDr.Reddys Laboratories Inc43598-45843598-0458-0443598-0458-36

Other NDCs under ANDA 209050

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209050
ProductStrengthForm · routeLabelerProduct NDC
sorafenibSorafenib 200 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC24979-715
sorafenibSorafenib 200 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-760

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