Prescription drug · ANDA
Cetrorelix acetate (Cetrorelix acetate for injection) NDC 67184-0605
Kit · Subcutaneous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0605-2 | 6718406050267184060502 | 1 KIT in 1 CARTON (67184-0605-2) * 1 mL in 1 VIAL, GLASS (67184-0567-1) * 1 mL in 1 SYRINGE, GLASS (67184-0568-1)Marketed from Apr 16, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Cetrorelix acetate
- Generic name (nonproprietary)
- cetrorelix acetate for injection
- Dosage form
- Kit
- Route
- Subcutaneous
- Labeler
- Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217776
- Marketing start
- Listing expires
- Identifiers
- Product ID 67184-0605_60fea8d3-ccd9-4714-80c5-b8f178f34ca3SPL ID 60fea8d3-ccd9-4714-80c5-b8f178f34ca3SPL set ID c1f35ca4-3536-44ca-ad0e-02f484019456RxCUI 283402UPC 0367184056811, 0367184056712
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467184060502followed by a unit qualifier and the quantityPackage 67184-0605-02. 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 Cetrorelix Acetate for Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Excerpt only. Read the full label for complete information.
About NDC 67184-0605
- What is NDC 67184-0605?
- 67184-0605 is the product NDC for Cetrorelix acetate (cetrorelix acetate for injection) kit, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetrorelix acetate (Cetrorelix Acetate for Injection).
- Who is the labeler?
- Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetrorelix acetate?
- 4 other product NDCs are listed under this name. See all Cetrorelix acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetrorelix acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| cetrorelix acetate | — | Kit | FRESENIUS KABI USA, LLC | 65219-292 | 65219-0292-77 |
| Cetrorelix acetatecetrorelix acetate for injection | — | KitSubcutaneous | Apotex Corp. | 60505-6270 | 60505-6270-01 |
| cetrorelix acetate | — | Kit | Gland Pharma Limited | 68083-600 | 68083-0600-01 |
| Cetrorelix Acetate | — | KitSubcutaneous | Meitheal Pharmaceuticals Inc. | 71288-558 | 71288-0558-90 |
Other NDCs under ANDA 217776
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 |
|---|---|---|---|---|
| Cetrorelix acetatecetrorelix acetate for injection | — | KitSubcutaneous | Apotex Corp. | 60505-6270 |