What is NDC 83390-107?

83390-107 is the product NDC for Clomiphene Citrate, Clomiphene citrate 50 mg/1 tablet, listed with the FDA by Cosette Pharmaceuticals NC Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals NC Laboratories, LLC, NDC labeler code 83390. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clomiphene Citrate?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clomiphene Citrate NDC 83390-107 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83390-107Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83390-0107Add 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
83390-107-09	83390010709	1 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 21, 2025
83390-107-30	83390010730	3 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 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: Cosette Pharmaceuticals NC Laboratories, LLCNDC labeler code 83390
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075528
Marketing start: Aug 21, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1SPL ID 3ce28083-f9f3-c59f-e063-6394a90a92e1SPL set ID 72719958-7454-4c54-9bb4-f3054d0c5d82RxCUI 1093060UNII 1B8447E7YI
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

N483390010709 followed by a unit qualifier and the quantity

Package 83390-0107-09. 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 Aug 21, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 83390-107

What is NDC 83390-107?: 83390-107 is the product NDC for Clomiphene Citrate, Clomiphene citrate 50 mg/1 tablet, listed with the FDA by Cosette Pharmaceuticals NC Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clomiphene Citrate.
What is the active ingredient?: Clomiphene citrate.
Who is the labeler?: Cosette Pharmaceuticals NC Laboratories, LLC, NDC labeler code 83390. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clomiphene Citrate?: 7 other product NDCs are listed under this name. See all Clomiphene Citrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clomiphene Citrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clomiphene Citrate	Clomiphene citrate 50 mg/1	TabletOral	Camber Pharmaceuticals Inc	31722-541	31722-0541-3231722-0541-33
Clomiphene Citrateclomiphene citrtae	Clomiphene citrate 50 mg/1	TabletOral	Acetris Pharma Holdings, LLC	52343-557	52343-0557-03
Clomiphene Citrate	Clomiphene citrate 50 mg/1	TabletOral	Accord Healthcare Inc.	16729-723	16729-0723-51
Clomiphene citrate	Clomiphene citrate 50 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-825	70954-0825-2070954-0825-30
Clomiphene Citrateclomiphene citrtae	Clomiphene citrate 50 mg/1	TabletOral	RISING PHARMA HOLDINGS, INC.	64980-690	64980-0690-0164980-0690-0364980-0690-90
Clomiphene Citrateclomiphene citrtae	Clomiphene citrate 50 mg/1	TabletOral	Appco Pharma LLC	55801-187	55801-0187-01
Clomiphene Citrate	Clomiphene citrate 50 mg/1	TabletOral	Advagen Pharma Ltd	72888-213	72888-0213-0872888-0213-58

Other NDCs under ANDA 075528

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

FDA NDC Directory listings under ANDA 075528
Product	Strength	Form · route	Labeler	Product NDC
Clomidclomiphene citrate	Clomiphene citrate 50 mg/1	TabletOral	Cosette Pharmaceuticals, Inc.	0713-0885
Clomidclomiphene citrate	Clomiphene citrate 50 mg/1	TabletOral	A-S Medication Solutions	50090-6500