Prescription drug · ANDA
Clomiphene Citrate (Clomiphene citrtae) NDC 55801-187
Clomiphene citrate 50 mg/1 · Tablet · Oral · Appco Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55801-187-01 | 5580101870155801018701 | 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 LLCNDC labeler code 55801
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216739
- Marketing start
- Listing expires
- 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
N455801018701followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 55801-187
- What is NDC 55801-187?
- 55801-187 is the product NDC for Clomiphene Citrate (clomiphene citrtae), Clomiphene citrate 50 mg/1 tablet, listed with the FDA by Appco Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clomiphene Citrate (Clomiphene Citrtae).
- What is the active ingredient?
- Clomiphene citrate.
- Who is the labeler?
- Appco Pharma LLC, NDC labeler code 55801. 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.
Related NDCs: other Clomiphene Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 Citrate | Clomiphene citrate 50 mg/1 | TabletOral | Cosette Pharmaceuticals NC Laboratories, LLC | 83390-107 | 83390-0107-0983390-0107-30 |
| Clomiphene Citrateclomiphene citrtae | Clomiphene citrate 50 mg/1 | TabletOral | RISING PHARMA HOLDINGS, INC. | 64980-690 | 64980-0690-0164980-0690-0364980-0690-90 |
| Clomiphene Citrate | Clomiphene citrate 50 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-213 | 72888-0213-0872888-0213-58 |
Other NDCs under ANDA 216739
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |