Prescription drug · BLA
Chorionic Gonadotropin NDC 63323-030
Kit · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-030-11 | 63323003011 | 1 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 21, 2011 |
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)
- Chorionic Gonadotropin
- Generic name (nonproprietary)
- chorionic gonadotropin
- Dosage form
- Kit
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 017067
- Marketing start
- Listing expires
- Identifiers
- Product ID 63323-030_386cd061-6485-428c-aec1-a4f58d90d339SPL ID 386cd061-6485-428c-aec1-a4f58d90d339SPL set ID f93b2baa-03ac-4650-b35a-20b818d712d6RxCUI 896854UPC 0363323030100, 0363323950019, 0363323030117
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
N463323003011followed by a unit qualifier and the quantityPackage 63323-0030-11. 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. 1. 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 admini…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 017067
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 |
|---|---|---|---|---|
| Chorionic Gonadotropin | — | Kit | NuCare Pharmaceuticals,Inc. | 68071-3815 |