Prescription drug · NDA
Lupron Depot (Leuprolide acetate) NDC 0074-3346
Kit · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-3346-03 | 0007433460300074334603 | 1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKETMarketed from Dec 23, 1995 | |
| 0074-3346-55 | 0007433465500074334655 | 1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKETMarketed from Mar 15, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Lupron Depot
- Generic name (nonproprietary)
- leuprolide acetate
- Dosage form
- Kit
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020517
- Marketing start
- Listing expires
- Identifiers
- Product ID 0074-3346_d7c452f3-aedd-4c8b-9e8e-46690c56a29cSPL ID d7c452f3-aedd-4c8b-9e8e-46690c56a29cSPL set ID cbc8f94e-7330-4465-05ad-16d64493a5ddRxCUI 1115257, 1115259, 1115462, 1115464, 1115467, 1115468, 1946521, 1946522
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
N400074334603followed by a unit qualifier and the quantityPackage 00074-3346-03. 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)
LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0074-3346
- What is NDC 0074-3346?
- 0074-3346 is the product NDC for Lupron Depot (leuprolide acetate) kit, listed with the FDA by AbbVie Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lupron Depot (Leuprolide acetate).
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lupron Depot?
- 5 other product NDCs are listed under this name. See all Lupron Depot NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lupron Depot products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3663 | 00074-3663-03 |
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3473 | 00074-3473-0300074-3473-55 |
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3683 | 00074-3683-0300074-3683-55 |
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3641 | 00074-3641-0300074-3641-71 |
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3642 | 00074-3642-0300074-3642-55 |
Other NDCs under NDA 020517
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 |
|---|---|---|---|---|
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3473 |
| Lupron Depotleuprolide acetate | — | Kit | AbbVie Inc. | 0074-3683 |