Prescription drug · ANDA
Clomid (clomiphene citrate) NDC 0713-0885
Clomiphene citrate 50 mg/1 · Tablet · Oral · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0885-09 | 00713088509 | 1 BLISTER PACK in 1 CARTON (0713-0885-09) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 12, 2022 | |
| 0713-0885-30 | 00713088530 | 3 BLISTER PACK in 1 CARTON (0713-0885-30) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 9, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Clomid
- Generic name (nonproprietary)
- clomiphene citrate
- Active ingredients
- Clomiphene citrate — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075528
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 0713-0885_2d02613b-bc31-bf2c-e063-6394a90a32ccSPL ID 2d02613b-bc31-bf2c-e063-6394a90a32ccSPL set ID 2ca373c1-4dba-4126-8616-5c533d606fe5RxCUI 1093060, 1093073UNII 1B8447E7YIUPC 0307130885300, 0307130885096
- 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
N400713088509followed by a unit qualifier and the quantityPackage 00713-0885-09. 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 .
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.
Other NDCs under ANDA 075528
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 |
|---|---|---|---|---|
| Clomidclomiphene citrate | Clomiphene citrate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6500 |
| Clomiphene Citrate | Clomiphene citrate 50 mg/1 | TabletOral | Cosette Pharmaceuticals NC Laboratories, LLC | 83390-107 |