Prescription drug · ANDA
Lenalidomide NDC 70710-1032
Lenalidomide 10 mg/1 · Capsule · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1032-1 | 70710103201 | 100 CAPSULE in 1 BOTTLE (70710-1032-1)Marketed from Sep 12, 2022 | |
| 70710-1032-7 | 70710103207 | 28 CAPSULE in 1 BOTTLE (70710-1032-7)Marketed from Sep 12, 2022 |
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)
- Lenalidomide
- Generic name (nonproprietary)
- lenalidomide
- Active ingredients
- Lenalidomide — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210154
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1032_d06dec99-06d1-4525-9caf-460747b53fbcSPL ID d06dec99-06d1-4525-9caf-460747b53fbcSPL set ID c98fb504-76d0-4c25-9c0b-412885828a7aRxCUI 602910, 602912, 643712, 643720, 1242231, 1428947UNII F0P408N6V4
- Pharmacologic class
- Thalidomide Analog
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470710103201followed by a unit qualifier and the quantityPackage 70710-1032-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Limitations of Use: Lenalidomide is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4 ). 1.1 Multiple Myeloma Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). 1.2 Myel…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210154
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 |
|---|---|---|---|---|
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1030 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1034 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1031 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1033 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1035 |
| Lenalidomide | Lenalidomide 10 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1678 |
| Lenalidomide | Lenalidomide 2.5 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1676 |
| Lenalidomide | Lenalidomide 5 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1677 |
| Lenalidomide | Lenalidomide 25 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1681 |
| Lenalidomide | Lenalidomide 15 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1679 |
| Lenalidomide | Lenalidomide 20 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1680 |