Prescription drug · NDA
Lupron Depot (Leuprolide acetate) NDC 0074-3641
Kit · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-3641-03 | 0007436410300074364103 | 1 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Oct 22, 1990 | |
| 0074-3641-71 | 0007436417100074364171 | 1 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Oct 22, 1990 · Sample package |
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 020011
- Marketing start
- Listing expires
- Identifiers
- Product ID 0074-3641_691f9b76-b15b-47c9-8df9-8ebe91999b45SPL ID 691f9b76-b15b-47c9-8df9-8ebe91999b45SPL set ID 00c486b0-bd7b-4898-834d-8c656e5e73cbRxCUI 797544, 1115457, 1115459
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
N400074364103followed by a unit qualifier and the quantityPackage 00074-3641-03. 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 3.75 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. ( 1.1 ) In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. ( 1.1 ) Limitations of Use: The total duration of therapy with LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density. ( 1.1 , 2.1 , 5.1 ) Uterine Leiomyomata (Fibroids) Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia cau…
Excerpt only. Read the full label for complete information.
About NDC 0074-3641
- What is NDC 0074-3641?
- 0074-3641 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. | 0074-3346 | 00074-3346-0300074-3346-55 |
| 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. | 0074-3642 | 00074-3642-0300074-3642-55 |