Prescription drug · NDA
Lamprene (Clofazimine) NDC 0078-1049
Clofazimine 50 mg/1 · Capsule, Liquid filled · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1049-05 | 00078104905 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0078-1049-05)Marketed from Jul 27, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Lamprene
- Generic name (nonproprietary)
- clofazimine
- Active ingredients
- Clofazimine — 50 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019500
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-1049_956e925d-695b-46c9-94e9-ce88ac51dfb3SPL ID 956e925d-695b-46c9-94e9-ce88ac51dfb3SPL set ID 2e07448f-f888-4747-80ab-570c1b621250RxCUI 197521, 206062UNII D959AE5USF
- Pharmacologic class
- Antimycobacterial
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
N400078104905followed by a unit qualifier and the quantityPackage 00078-1049-05. 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)
LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. ( 1.2 ) 1.1 Lepromatous Leprosy LAMPRENE is indicated in combination with other anti-leprosy drugs for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy, and lepromatous leprosy complicated by erythema nodosum leprosum. 1.2 Usage To prevent the development of drug-resistance, LAMPRENE should be used o…
Excerpt only. Read the full label for complete information.
About NDC 0078-1049
- What is NDC 0078-1049?
- 0078-1049 is the product NDC for Lamprene (clofazimine), Clofazimine 50 mg/1 capsule, liquid filled, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamprene (Clofazimine).
- What is the active ingredient?
- Clofazimine.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamprene?
- 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.