Prescription drug · ANDA
MiloPhene (Clomiphene citrate) NDC 35573-470
Clomiphene citrate 50 mg/1 · Tablet · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-470-30 | 35573047030 | 30 TABLET in 1 BOTTLE (35573-470-30)Marketed from Aug 15, 2025 | |
| 35573-470-75 | 35573047075 | 10 TABLET in 1 BOTTLE (35573-470-75)Marketed from Dec 1, 2025 |
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)
- MiloPhene
- Generic name (nonproprietary)
- clomiphene citrate
- Active ingredients
- Clomiphene citrate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLCNDC labeler code 35573
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072196
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfedSPL ID a7991ccf-26b1-4ab0-bf9e-175152dccfedSPL set ID b56131e5-efc7-43af-ac13-4a2ae918df4eRxCUI 1093060, 2723329UNII 1B8447E7YIUPC 0335573470753, 0335573470302
- 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
N435573047030followed by a unit qualifier and the quantityPackage 35573-0470-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome ), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests …
Excerpt only. Read the full label for complete information.
About NDC 35573-470
- What is NDC 35573-470?
- 35573-470 is the product NDC for MiloPhene (clomiphene citrate), Clomiphene citrate 50 mg/1 tablet, listed with the FDA by Burel Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- MiloPhene (Clomiphene Citrate).
- What is the active ingredient?
- Clomiphene citrate.
- Who is the labeler?
- Burel Pharmaceuticals, LLC, NDC labeler code 35573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for MiloPhene?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.