Prescription drug · ANDA
Romidepsin NDC 70121-2250
Romidepsin 5 mg/mL · Injection, Solution, Concentrate · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-2250-1 | 7012122500170121225001 | 1 VIAL in 1 CARTON (70121-2250-1) / 5.5 mL in 1 VIALMarketed from Jun 2, 2026 |
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
- Active ingredients
- Romidepsin — 5 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 70121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219099
- Marketing start
- Listing expires
- Other FDA classes
- Bile Salt Export Pump Inhibitors (Mechanism)Histone Deacetylase Inhibitors (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 70121-2250_a007605f-1e3d-4174-b62c-999ebbe27ed5SPL ID a007605f-1e3d-4174-b62c-999ebbe27ed5SPL set ID 61894b77-f29c-4a81-ad85-bd3a698233a4RxCUI 2289413UNII CX3T89XQBKUPC 0370121225010
- Pharmacologic class
- Histone Deacetylase Inhibitor
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
N470121225001followed by a unit qualifier and the quantityPackage 70121-2250-01. 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 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 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 70121-2250
- What is NDC 70121-2250?
- 70121-2250 is the product NDC for Romidepsin, Romidepsin 5 mg/mL injection, solution, concentrate, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Romidepsin.
- What is the active ingredient?
- Romidepsin.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 70121. 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 | — | Kit | Fresenius Kabi USA, LLC | 63323-926 | 63323-0926-88 |