Prescription drug · ANDA
Clomiphene Citrate NDC 16729-723
Clomiphene citrate 50 mg/1 · Tablet · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-723-51 | 16729072351 | 1 BLISTER PACK in 1 CARTON (16729-723-51) / 30 TABLET in 1 BLISTER PACKMarketed from Nov 21, 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)
- Clomiphene Citrate
- Generic name (nonproprietary)
- clomiphene citrate
- Active ingredients
- Clomiphene citrate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219406
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 16729-723_44e70204-6bed-9d96-e063-6294a90aa3cdSPL ID 44e70204-6bed-9d96-e063-6294a90aa3cdSPL set ID 79f64995-7425-44c6-9f44-f7d20daeff65RxCUI 1093060UNII 1B8447E7YIUPC 0316729723442
- 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
N416729072351followed by a unit qualifier and the quantityPackage 16729-0723-51. 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.