Home NDC 0078-1049 Lamprene
Product NDC 0078-1049
11-digit product format 000781049
Labeler code 0078
Product ID 0078-1049_956e925d-695b-46c9-94e9-ce88ac51dfb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clofazimine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA019500
Marketing category NDA
Marketing start 1986-12-15
Substance CLOFAZIMINE
Active strength 50 mg/1
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019500-001 LAMPRENE CLOFAZIMINE 100MG CAPSULE / ORAL 1986-12-15 N019500-002 LAMPRENE CLOFAZIMINE 50MG CAPSULE / ORAL RLD 1986-12-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019500-001 LAMPRENE 100MG CAPSULE / ORAL 1986-12-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019500-002 LAMPRENE 50MG CAPSULE / ORAL RLD 1986-12-15 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lamprene
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOFAZIMINE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D959AE5USF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197521 Internal RxNorm lookup 206062 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0078-1049-05 00078104905 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0078-1049-05) 2026-07-27 No No Current