Prescription drug · ANDA
Methoxsalen NDC 64380-752
Methoxsalen 10 mg/1 · Capsule, Liquid filled · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-752-16 | 64380075216 | 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS (64380-752-16)Marketed from Dec 8, 2016 |
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)
- Methoxsalen
- Generic name (nonproprietary)
- methoxsalen
- Active ingredients
- Methoxsalen — 10 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202687
- Marketing start
- Listing expires
- Other FDA classes
- Photoabsorption (Mechanism)Photosensitizing Activity (Physiologic effect)Psoralens (Chemical structure)
- Identifiers
- Product ID 64380-752_54fe37e7-293d-5931-e063-6394a90a256cSPL ID 54fe37e7-293d-5931-e063-6394a90a256cSPL set ID a6ec8292-9189-4ebd-862a-e1725eb29eefRxCUI 1812434UNII U4VJ29L7BQUPC 0364380752165
- Pharmacologic class
- Photoactivated Radical Generator; Psoralen
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
N464380075216followed by a unit qualifier and the quantityPackage 64380-0752-16. 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)
III. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
Excerpt only. Read the full label for complete information.
About NDC 64380-752
- What is NDC 64380-752?
- 64380-752 is the product NDC for Methoxsalen, Methoxsalen 10 mg/1 capsule, liquid filled, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methoxsalen.
- What is the active ingredient?
- Methoxsalen.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methoxsalen?
- 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.