Prescription drug · BLA
Pregnyl (choriogonadotropin alfa) NDC 78206-150
Kit · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-150-01 | 78206015001 | 1 KIT in 1 CARTON (78206-150-01) * 10 mL in 1 VIAL, MULTI-DOSE (78206-150-99) * 10 mL in 1 VIAL (78206-151-89)Marketed from Jun 2, 2023 |
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)
- Pregnyl
- Generic name (nonproprietary)
- choriogonadotropin alfa
- Dosage form
- Kit
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 017692
- Marketing start
- Listing expires
- Identifiers
- Product ID 78206-150_11f90621-6a2d-4c75-9f32-3e6180df7618SPL ID 11f90621-6a2d-4c75-9f32-3e6180df7618SPL set ID 1e94155f-19be-4944-b197-be4edbb4faf9RxCUI 896854, 896856
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N478206015001followed by a unit qualifier and the quantityPackage 78206-0150-01. 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 AND USAGE HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS. Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following hCG administrati…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 017692
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 |
|---|---|---|---|---|
| Pregnylchoriogonadotropin alfa | — | Kit | A-S Medication Solutions | 50090-7089 |