Prescription drug · ANDA
leuprolide acetate NDC 47335-936
Kit · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-936-40 | 4733509364047335093640 | 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKETMarketed from Dec 15, 2014 |
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)
- leuprolide acetate
- Generic name (nonproprietary)
- leuprolide acetate
- Dosage form
- Kit
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078885
- Marketing start
- Listing expires
- Identifiers
- Product ID 47335-936_ebfec8b9-a556-4304-af58-2c305db723afSPL ID ebfec8b9-a556-4304-af58-2c305db723afSPL set ID a3b01473-30c7-4945-bd60-2484221aaaadRxCUI 545835, 797544UPC 0347335936407
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
N447335093640followed by a unit qualifier and the quantityPackage 47335-0936-40. 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 47335-936
- What is NDC 47335-936?
- 47335-936 is the product NDC for leuprolide acetate kit, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 | — | Kit | Zydus Lifesciences Limited | 70771-1687 | 70771-1687-03 |
| 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 |