Lamprene

Product NDC: 0078-1049
Requested package NDC: 0078-1049-05
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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2e07448f-f888-4747-80ab-570c1b621250	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamprene	CLOFAZIMINE	Novartis Pharmaceuticals Corporation	2e07448f-f888-4747-80ab-570c1b621250	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019500 application number: NDA019500 ndc (package): 0078-1049-05 ndc (product): 0078-1049 ndc11 (package): 00078104905

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D959AE5USF	CLOFAZIMINE	2030-63-9	CLOFAZIMINE

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