Prescription drug · ANDA
Leuprolide Acetate NDC 70771-1687
Kit · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1687-3 | 7077116870370771168703 | 1 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70771-1686-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70771-1765-8)Marketed from Jan 8, 2026 |
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)
- Leuprolide Acetate
- Generic name (nonproprietary)
- leuprolide acetate
- Dosage form
- Kit
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215826
- Marketing start
- Listing expires
- Identifiers
- Product ID 70771-1687_ebf565fd-e894-45ad-8b0b-8b94bdf375d1SPL ID ebf565fd-e894-45ad-8b0b-8b94bdf375d1SPL set ID 4bae0e2a-dd36-4987-85ee-36a52e642ec7RxCUI 545835, 797544UPC 0370710176815
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
N470771168703followed by a unit qualifier and the quantityPackage 70771-1687-03. 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 Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Excerpt only. Read the full label for complete information.
About NDC 70771-1687
- What is NDC 70771-1687?
- 70771-1687 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leuprolide Acetate.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leuprolide Acetate?
- 11 other product NDCs are listed under this name. See all Leuprolide Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leuprolide 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) |
|---|---|---|---|---|---|
| Leuprolide Acetate | Leuprolide acetate 1 mg/.2mL | InjectionSubcutaneous | Endo USA, Inc. | 42023-259 | 42023-0259-00 |
| Leuprolide Acetate | — | Kit | Zydus Pharmaceuticals USA Inc. | 70710-1769 | 70710-1769-03 |
| leuprolide acetate | — | KitSubcutaneous | PAI Holdings, LLC dba PAI Pharma | 0121-2106 | 00121-2106-02 |
| leuprolide acetate | — | KitSubcutaneous | UBI Pharma Inc. | 72843-591 | 72843-0591-99 |
| Leuprolide Acetate | — | KitSubcutaneous | Meitheal Pharmaceuticals Inc | 71288-569 | 71288-0569-90 |
| Leuprolide Acetate | — | KitSubcutaneous | NorthStar RxLLC | 72603-344 | 72603-0344-01 |
| leuprolide acetate | — | KitSubcutaneous | Amneal Pharmaceuticals LLC | 70121-2537 | 70121-2537-06 |
| Leuprolide Acetate | — | Kit | Eugia US LLC | 55150-478 | 55150-0478-01 |
| Leuprolide Acetate | — | Kit | VGYAAN Pharmaceuticals LLC | 72664-611 | 72664-0611-28 |
| leuprolide acetate | — | Kit | Sun Pharmaceutical Industries, Inc. | 47335-936 | 47335-0936-40 |
Other NDCs under ANDA 215826
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 |
|---|---|---|---|---|
| Leuprolide Acetate | — | Kit | Zydus Pharmaceuticals USA Inc. | 70710-1769 |