Prescription drug · ANDA
toremifene citrate NDC 72205-050
Toremifene citrate 60 mg/1 · Tablet · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-050-30 | 72205005030 | 30 TABLET in 1 BOTTLE (72205-050-30)Marketed from Sep 2, 2020 |
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
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212818
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 72205-050_199a7f12-59c6-430f-bc07-a63af2fc7589SPL ID 199a7f12-59c6-430f-bc07-a63af2fc7589SPL set ID e897546b-4136-4cb5-a262-d94cf3fa3298RxCUI 313428UNII 2498Y783QTUPC 0372205050303
- 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
N472205005030followed by a unit qualifier and the quantityPackage 72205-0050-30. 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 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 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 72205-050
- What is NDC 72205-050?
- 72205-050 is the product NDC for toremifene citrate, Toremifene citrate 60 mg/1 tablet, listed with the FDA by Novadoz Pharmaceuticals LLC. 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?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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 | Rising Pharma Holdings, Inc. | 64980-404 | 64980-0404-03 |