Prescription drug · ANDA
sorafenib NDC 51990-201
Sorafenib 200 mg/1 · Tablet, Film coated · Oral · Yabao Pharmaceutical Co., Ltd. Beijing
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51990-201-06 | 51990020106 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06)Marketed from Dec 1, 2022 | |
| 51990-201-12 | 51990020112 | 120 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
- 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
N451990020106followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 209050
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.