Prescription drug · NDA
Eligard (Leuprolide acetate) NDC 62935-756
Leuprolide acetate 7.5 mg/.25mL · Injection, Suspension, Extended release · Subcutaneous · TOLMAR Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62935-756-80 | 6293507568062935075680 | 1 SYRINGE in 1 CARTON (62935-756-80) / .25 mL in 1 SYRINGEMarketed from Nov 1, 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)
- Eligard
- Generic name (nonproprietary)
- leuprolide acetate
- Active ingredients
- Leuprolide acetate — 7.5 mg/.25mL
- Dosage form
- Injection, Suspension, Extended release
- Route
- Subcutaneous
- Labeler
- TOLMAR Inc.NDC labeler code 62935
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021343
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62935-756_58cff066-4345-4624-8868-4c232a051a5dSPL ID 58cff066-4345-4624-8868-4c232a051a5dSPL set ID b7b679a9-6823-4ef8-8d31-3ab5058ffcfcRxCUI 752884, 752889, 752894, 752899, 825325, 825333, 825334, 825335UNII 37JNS02E7V
- 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
N462935075680followed by a unit qualifier and the quantityPackage 62935-0756-80. 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)
ELIGARD is indicated for the treatment of advanced prostate cancer. ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62935-756
- What is NDC 62935-756?
- 62935-756 is the product NDC for Eligard (leuprolide acetate), Leuprolide acetate 7.5 mg/.25mL injection, suspension, extended release, listed with the FDA by TOLMAR Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eligard (Leuprolide acetate).
- What is the active ingredient?
- Leuprolide acetate.
- Who is the labeler?
- TOLMAR Inc., NDC labeler code 62935. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eligard?
- 7 other product NDCs are listed under this name. See all Eligard NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eligard products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eligardleuprolide acetate | Leuprolide acetate 30 mg/.5mL | Injection, Suspension, Extended releaseSubcutaneous | TOLMAR Inc. | 62935-306 | 62935-0306-40 |
| Eligardleuprolide acetate | Leuprolide acetate 22.5 mg/.375mL | Injection, Suspension, Extended releaseSubcutaneous | TOLMAR Inc. | 62935-227 | 62935-0227-10 |
| Eligardleuprolide acetate | Leuprolide acetate 45 mg/.375mL | Injection, Suspension, Extended releaseSubcutaneous | TOLMAR Inc. | 62935-461 | 62935-0461-50 |
| Eligardleuprolide acetate | — | KitSubcutaneous | TOLMAR Inc. | 62935-453 | 62935-0453-45 |
| Eligardleuprolide acetate | — | KitSubcutaneous | TOLMAR Inc. | 62935-303 | 62935-0303-30 |
| Eligardleuprolide acetate | — | KitSubcutaneous | TOLMAR Inc. | 62935-223 | 62935-0223-05 |
| Eligardleuprolide acetate | — | KitSubcutaneous | TOLMAR Inc. | 62935-753 | 62935-0753-75 |
Other NDCs under NDA 021343
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 |
|---|---|---|---|---|
| Eligardleuprolide acetate | — | KitSubcutaneous | TOLMAR Inc. | 62935-753 |
| Vabrintyleuprolide acetate | Leuprolide acetate 7.5 mg/.25mL | Injection, Suspension, Extended releaseSubcutaneous | URONOVA PHARMACEUTICALS, INC. | 85043-075 |