Prescription drug · ANDA
Clomiphene citrate NDC 70954-825
Clomiphene citrate 50 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-825-20 | 70954082520 | 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10)Marketed from Oct 17, 2025 | |
| 70954-825-30 | 70954082530 | 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10)Marketed from Oct 17, 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
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219781
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 70954-825_886faf33-d80b-4929-a5a7-2f2376fdeb68SPL ID 886faf33-d80b-4929-a5a7-2f2376fdeb68SPL set ID b56e04f0-490d-4f10-a0ed-31c288f4f4c5RxCUI 1093060UNII 1B8447E7YIUPC 0370954825302
- 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
N470954082520followed by a unit qualifier and the quantityPackage 70954-0825-20. 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 tablets are 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 tablets 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 appr…
Excerpt only. Read the full label for complete information.
About NDC 70954-825
- What is NDC 70954-825?
- 70954-825 is the product NDC for Clomiphene citrate, Clomiphene citrate 50 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 | 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 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 |