Prescription drug · NDA
Thalomid (Thalidomide) NDC 59572-220
Thalidomide 200 mg/1 · Capsule · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-220-96 | 59572022096 | 3 BLISTER PACK in 1 BOX (59572-220-96) / 28 CAPSULE in 1 BLISTER PACK (59572-220-16)Marketed from Jun 20, 2003 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Thalomid
- Generic name (nonproprietary)
- thalidomide
- Active ingredients
- Thalidomide — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020785
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Immunologically Active Molecule Activity (Physiologic effect)
- Identifiers
- Product ID 59572-220_58b287d1-24f5-4dfe-84ca-898a8a5b9302SPL ID 58b287d1-24f5-4dfe-84ca-898a8a5b9302SPL set ID 2eda833b-1357-4ed4-a093-194524fcb061RxCUI 200390, 213360, 360176, 360177, 404449, 404450, 700416, 700418UNII 4Z8R6ORS6L
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
N459572022096followed by a unit qualifier and the quantityPackage 59572-0220-96. 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)
• THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). ( 1.1 ) • THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. ( 1.2 ) 1.1 Multiple Myeloma THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM) [see Clinical Studies (…
Excerpt only. Read the full label for complete information.
About NDC 59572-220
- What is NDC 59572-220?
- 59572-220 is the product NDC for Thalomid (thalidomide), Thalidomide 200 mg/1 capsule, listed with the FDA by Celgene Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Thalomid (Thalidomide).
- What is the active ingredient?
- Thalidomide.
- Who is the labeler?
- Celgene Corporation, NDC labeler code 59572. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Thalomid?
- 3 other product NDCs are listed under this name. See all Thalomid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Thalomid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Thalomidthalidomide | Thalidomide 150 mg/1 | CapsuleOral | Celgene Corporation | 59572-215 | 59572-0215-93 |
| Thalomidthalidomide | Thalidomide 50 mg/1 | CapsuleOral | Celgene Corporation | 59572-205 | 59572-0205-9459572-0205-97 |
| Thalomidthalidomide | Thalidomide 100 mg/1 | CapsuleOral | Celgene Corporation | 59572-210 | 59572-0210-95 |
Other NDCs under NDA 020785
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 |
|---|---|---|---|---|
| Thalomidthalidomide | Thalidomide 50 mg/1 | CapsuleOral | Celgene Corporation | 59572-205 |
| Thalomidthalidomide | Thalidomide 100 mg/1 | CapsuleOral | Celgene Corporation | 59572-210 |
| Thalomidthalidomide | Thalidomide 150 mg/1 | CapsuleOral | Celgene Corporation | 59572-215 |