NDC codes

FDA NDC Directory
Product NDC (as listed)0078-1049Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00078-1049Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0078-1049-0500078104905100 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

N400078104905 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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