Prescription drug · ANDA
leuprolide acetate NDC 72843-591
Kit · Subcutaneous · UBI Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72843-591-99 | 7284305919972843059199 | 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKETMarketed from Oct 25, 2024 |
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
- Route
- Subcutaneous
- Labeler
- UBI Pharma Inc.NDC labeler code 72843
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217957
- Marketing start
- Listing expires
- Identifiers
- Product ID 72843-591_4e3665c7-c296-c3d1-e063-6294a90ada86SPL ID 4e3665c7-c296-c3d1-e063-6294a90ada86SPL set ID cd46628f-055f-4da9-8c38-fa69af34eb4dRxCUI 545835, 797544UPC 0072843590017
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
N472843059199followed by a unit qualifier and the quantityPackage 72843-0591-99. 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 72843-591
- What is NDC 72843-591?
- 72843-591 is the product NDC for leuprolide acetate kit, listed with the FDA by UBI Pharma 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?
- UBI Pharma Inc., NDC labeler code 72843. 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 | 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 217957
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 | — | KitSubcutaneous | PAI Holdings, LLC dba PAI Pharma | 0121-2106 |