Prescription drug · NDA
Camcevi (Leuprolide) NDC 69448-023
Leuprolide mesylate 42 mg/.37g · Injection, Emulsion · Subcutaneous · Accord BioPharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69448-023-63 | 6944800236369448002363 | 1 SYRINGE in 1 CARTON (69448-023-63) / .37 g in 1 SYRINGEMarketed from May 19, 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)
- Camcevi
- Generic name (nonproprietary)
- leuprolide
- Active ingredients
- Leuprolide mesylate — 42 mg/.37g
- Dosage form
- Injection, Emulsion
- Route
- Subcutaneous
- Labeler
- Accord BioPharma, Inc.NDC labeler code 69448
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211488
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69448-023_57c00790-884c-599e-e063-6394a90a5e2bSPL ID 57c00790-884c-599e-e063-6394a90a5e2b
- Pharmacologic class
- Gonadotropin Releasing Hormone Receptor Agonist
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
N469448002363followed by a unit qualifier and the quantityPackage 69448-0023-63. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69448-023
- What is NDC 69448-023?
- 69448-023 is the product NDC for Camcevi (leuprolide), Leuprolide mesylate 42 mg/.37g injection, emulsion, listed with the FDA by Accord BioPharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Camcevi (Leuprolide).
- What is the active ingredient?
- Leuprolide mesylate.
- Who is the labeler?
- Accord BioPharma, Inc., NDC labeler code 69448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Camcevi?
- 1 other product NDC are listed under this name. See all Camcevi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Camcevi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Camcevileuprolide | Leuprolide mesylate 42 mg/.37g | Injection, EmulsionSubcutaneous | Accord BioPharma, Inc. | 69448-014 | 69448-0014-63 |
Other NDCs under NDA 211488
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 |
|---|---|---|---|---|
| Camcevileuprolide | Leuprolide mesylate 42 mg/.37g | Injection, EmulsionSubcutaneous | Accord BioPharma, Inc. | 69448-014 |