Prescription drug · NDA
Valchlor (Mechlorethamine hydrochloride) NDC 69639-120
Mechlorethamine .012 g/60g · Gel · Topical · Helsinn Therapeutics (U.S.), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69639-120-01 | 69639012001 | 1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBEMarketed from Nov 8, 2018 |
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)
- Valchlor
- Generic name (nonproprietary)
- mechlorethamine hydrochloride
- Active ingredients
- Mechlorethamine — .012 g/60g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Helsinn Therapeutics (U.S.), Inc.NDC labeler code 69639
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202317
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 69639-120_942707af-a16c-4a62-b733-103e0fac915eSPL ID 942707af-a16c-4a62-b733-103e0fac915eSPL set ID 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57RxCUI 1437711, 1437713UNII 50D9XSG0VRUPC 0369639120016
- Pharmacologic class
- Alkylating Drug
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469639012001followed by a unit qualifier and the quantityPackage 69639-0120-01. 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)
VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 69639-120
- What is NDC 69639-120?
- 69639-120 is the product NDC for Valchlor (mechlorethamine hydrochloride), Mechlorethamine .012 g/60g gel, listed with the FDA by Helsinn Therapeutics (U.S.), Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valchlor (Mechlorethamine hydrochloride).
- What is the active ingredient?
- Mechlorethamine.
- Who is the labeler?
- Helsinn Therapeutics (U.S.), Inc., NDC labeler code 69639. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valchlor?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.