Prescription drug · ANDA
Romidepsin NDC 70710-2183
Kit · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2183-3 | 7071021830370710218303 | 1 KIT in 1 CARTON (70710-2183-3) * 2 mL in 1 VIAL, GLASS (70710-2181-1) * 2.2 mL in 1 VIAL, GLASS (70710-2182-1)Marketed from Nov 1, 2026 · Sample package |
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)
- Romidepsin
- Generic name (nonproprietary)
- romidepsin
- Dosage form
- Kit
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220783
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-2183_d4d16f51-b1f4-4705-8355-f5d89dc05581SPL ID d4d16f51-b1f4-4705-8355-f5d89dc05581SPL set ID 7e306d8e-0e00-4f1c-b179-2027d44092ceUPC 0370710218218
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
N470710218303followed by a unit qualifier and the quantityPackage 70710-2183-03. 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)
Romidepsin for injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. Romidepsin for injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 70710-2183
- What is NDC 70710-2183?
- 70710-2183 is the product NDC for Romidepsin kit, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Romidepsin.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Romidepsin?
- 1 other product NDC are listed under this name. See all Romidepsin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Romidepsin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Romidepsin | Romidepsin 5 mg/mL | Injection, Solution, ConcentrateIntravenous | Amneal Pharmaceuticals LLC | 70121-2250 | 70121-2250-01 |
| Romidepsin | — | Kit | Fresenius Kabi USA, LLC | 63323-926 | 63323-0926-88 |
Other NDCs under ANDA 220783
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 |
|---|---|---|---|---|
| Romidepsin | — | Kit | Zydus Lifesciences Limited | 70771-1986 |