Prescription drug · ANDA
toremifene citrate NDC 64980-404
Toremifene citrate 60 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-404-03 | 64980040403 | 30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03)Marketed from Jan 18, 2019 |
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)
- toremifene citrate
- Generic name (nonproprietary)
- toremifene citrate
- Active ingredients
- Toremifene citrate — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208813
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 64980-404_6aa927e6-a0b9-4904-aa11-e5a3f52cee47SPL ID 6aa927e6-a0b9-4904-aa11-e5a3f52cee47SPL set ID dbde10d5-c689-428f-841d-b34aa5addf2dRxCUI 313428UNII 2498Y783QTUPC 0364980404037
- Pharmacologic class
- Estrogen Agonist/Antagonist
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
N464980040403followed by a unit qualifier and the quantityPackage 64980-0404-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Excerpt only. Read the full label for complete information.
About NDC 64980-404
- What is NDC 64980-404?
- 64980-404 is the product NDC for toremifene citrate, Toremifene citrate 60 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- toremifene citrate.
- What is the active ingredient?
- Toremifene citrate.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for toremifene citrate?
- 1 other product NDC are listed under this name. See all toremifene citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other toremifene citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| toremifene citrate | Toremifene citrate 60 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-050 | 72205-0050-30 |