Home NDC 50419-750 LAMPIT
Product NDC 50419-750
11-digit product format 504190750
Labeler code 50419
Product ID 50419-750_9b14492a-5ae2-4d0a-85c0-212636daf8cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nifurtimox
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA213464
Marketing category NDA
Marketing start 2020-10-01
Substance NIFURTIMOX
Active strength 30 mg/1
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 1 .
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 N213464-001 LAMPIT NIFURTIMOX 30MG TABLET / ORAL RLD 2020-08-06 N213464-002 LAMPIT NIFURTIMOX 120MG TABLET / ORAL RLD, RS 2020-08-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213464-001 ODE-319 2027-08-06 N213464-002 ODE-319 2027-08-06
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 2 · 74 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 2026-02-19 14:30 UTC 2026-02 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213464-001 LAMPIT 30MG TABLET / ORAL RLD 2020-08-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213464-002 LAMPIT 120MG TABLET / ORAL RLD, RS 2020-08-06 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LAMPIT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIFURTIMOX 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M84I3K7C2O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 430512 Internal RxNorm lookup 2395842 Internal RxNorm lookup 2397991 Internal RxNorm lookup 2397994 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-750-01 LAMPIT 1 in 1 CARTON TABLET, FILM COATED 1 9 50419-750-01 LAMPIT 100 in 1 BOTTLE TABLET, FILM COATED 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-750 LAMPIT (NIFURTIMOX) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241211_90d09714-a8b1-4696-8ada-f99dc54d0721.zip
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 LAMPIT NIFURTIMOX Bayer HealthCare Pharmaceuticals Inc. 90d09714-a8b1-4696-8ada-f99dc54d0721 2026-03-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 213464 application number: NDA213464 ndc (product): 50419-750
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-750-01 50419075001 1 BOTTLE in 1 CARTON (50419-750-01) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-10-01 0000-00-00 No No Current