Quick answers
- What is Clomiphene citrate used for?
- The FDA-approved label (Clomid, Cosette Pharmaceuticals, Inc., January 31, 2025) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clomiphene citrate have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Clomiphene citrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clomiphene citrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Clomiphene citrate?
- 11 companies list prescription products of Clomiphene citrate in the FDA NDC Directory, including Burel Pharmaceuticals, LLC, ANI Pharmaceuticals, Inc. and Rising Pharma Holdings, Inc..
What Clomiphene citrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Clomid, Cosette Pharmaceuticals, Inc., effective January 31, 2025. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| clomiphene citrate 50 mg tablet | Generic | $4.06 per tablet |
| clomiphene citrate 50 mg tablet | Brand: Clomid | $16.65 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Burel Pharmaceuticals, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Acetris Pharma Holdings, LLC1 product
- Appco Pharma LLC1 product
- A-S Medication Solutions1 product
- Cosette Pharmaceuticals, Inc.1 product
- Accord Healthcare Inc.1 product
- Advagen Pharma Ltd1 product
- Cosette Pharmaceuticals NC Laboratories, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA072196Granata Bio Corp · December 20, 1988
- ANDA075528Cosette · August 30, 1999
- ANDA216739Appco · November 8, 2024
- ANDA216545Rubicon Research · November 12, 2024
- ANDA219406Accord Hlthcare · October 3, 2025
- ANDA219781Novitium Pharma · October 17, 2025
- ANDA220673Ascent Pharms Inc · May 15, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1093060, 1093073, 2723329 |
|---|---|
| SPL set ID of the quoted label | 2ca373c1-4dba-4126-8616-5c533d606fe5 |
| FDA labels (SPL) | 11 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | CLOMIPHENE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clomid, Cosette Pharmaceuticals, Inc., effective January 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →