Clomiphene Citrate (clomiphene citrtae) NDC 55801-187

NDC codes

FDA NDC Directory

Product NDC (as listed)55801-187Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55801-0187Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55801-187-01	55801018701	30 TABLET in 1 BOTTLE (55801-187-01)Marketed from Nov 18, 2024

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 citrtae
Active ingredients: Clomiphene citrate — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Appco Pharma LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216739
Marketing start: Nov 18, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 55801-187_b22cc371-c969-4446-8cba-32a7e469ae80SPL ID b22cc371-c969-4446-8cba-32a7e469ae80SPL set ID 2d257ec2-827c-4bc2-8f17-cf24520c3cadRxCUI 1093060UNII 1B8447E7YIUPC 0364980690034
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

N455801018701 followed by a unit qualifier and the quantity

Package 55801-0187-01. 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 Nov 18, 2024.

Indications (excerpt from the label)

INDICATIONS & 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 ma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216739

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216739
Product	Strength	Form · route	Labeler	Product NDC
Clomiphene Citrateclomiphene citrtae	Clomiphene citrate 50 mg/1	TabletOral	Acetris Pharma Holdings, LLC	52343-557
Clomiphene Citrateclomiphene citrtae	Clomiphene citrate 50 mg/1	TabletOral	RISING PHARMA HOLDINGS, INC.	64980-690