Home NDC 50419-747 Biltricide
Product NDC 50419-747
11-digit product format 504190747
Labeler code 50419
Product ID 50419-747_c9ab40f0-8a11-486f-be88-765af55b6484
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name praziquantel
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA018714
Marketing category NDA
Marketing start 2011-04-21
Substance PRAZIQUANTEL
Active strength 600 mg/1
Pharmacologic classes Anthelmintic [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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018714-001 BILTRICIDE PRAZIQUANTEL 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1982-12-29
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 · 41 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 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL RLD 1982-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD 1982-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018714-001 BILTRICIDE 600MG TABLET / ORAL AB RLD, RS 1982-12-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Biltricide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAZIQUANTEL 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6490C9U457 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198140 Internal RxNorm lookup 208975 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-747-01 Biltricide 6 in 1 BOTTLE TABLET, FILM COATED 6 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAZIQUANTEL ACTIVE INGREDIENT 6490C9U457 BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 PRAZIQUANTEL ACTIVE MOIETY 6490C9U457 BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-747 BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240110_34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50419-747-01 50419074701 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01) 2011-04-21 0000-00-00 No No Current