Biltricide

Product NDC
76413-146
11-digit product format
764130146
Labeler code
76413
Product ID
76413-146_f4b54a8c-fefe-4290-bd07-3d13b4699730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
praziquantel
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
NDA018714
Marketing category
NDA
Marketing start
2011-04-21
Marketing end
0000-00-00
Substance
PRAZIQUANTEL
Active strength
600 mg/1
Pharmacologic classes
Anthelmintic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-146IInactivated by FDA2026-08-07
excluded packagepackage76413-14676413-146-01IInactivated by FDA2026-08-07
excluded packagepackage76413-14676413-146-02IInactivated by FDA2026-08-07
excluded packagepackage76413-14676413-146-03IInactivated by FDA2026-08-07
excluded packagepackage76413-14676413-146-04IInactivated by FDA2026-08-07
excluded packagepackage76413-14676413-146-05IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 126 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-146-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-146-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-146-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-146-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-146-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-146-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-146-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-146-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-146-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-146-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-146-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-146-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-146-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-146-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-146-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-146-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-146-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-146-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-146-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-146-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-146-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-146-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-146-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-146-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-146-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-146-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-146-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-146-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-146-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-146-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-146-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-146-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-146-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-146-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-146-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-146-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-146-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-146-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-146-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-146-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-146-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-146-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-146-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-146-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-146-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-146-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-146-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-146-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-146-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-146-05ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018714-001BILTRICIDEPRAZIQUANTEL600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1982-12-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018714-001BILTRICIDE600MGTABLET / ORALABRLD1982-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018714-001BILTRICIDE600MGTABLET / ORALRLD1982-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018714-001BILTRICIDE600MGTABLET / ORALABRLD1982-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018714-001BILTRICIDE600MGTABLET / ORALABRLD1982-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018714-001BILTRICIDE600MGTABLET / ORALABRLD, RS1982-12-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018714-001AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018714-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018714-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018714-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018714-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018714-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018714-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018714-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018714-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018714-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018714-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018714-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018714-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018714-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018714-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018714-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018714-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018714-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018714-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018714-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018714-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018714-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018714-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018714-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018714-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018714-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018714-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018714-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018714-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018714-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018714-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cabd598-669e-43ab-9753-4aec00a484cbProduct name120180125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-146-01Biltricide1 in 1 BOTTLETABLET, FILM COATED11
76413-146-02Biltricide2 in 1 BOTTLETABLET, FILM COATED21
76413-146-03Biltricide3 in 1 BOTTLETABLET, FILM COATED31
76413-146-04Biltricide4 in 1 BOTTLETABLET, FILM COATED41
76413-146-05Biltricide5 in 1 BOTTLETABLET, FILM COATED51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-146BILTRICIDE (PRAZIQUANTEL) TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 5 package rows20170824_d6791c7c-749a-4595-937b-32229dd59902.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiltricidePRAZIQUANTELBayer HealthCare Pharmaceuticals Inc.34ce1cdd-648e-4f1e-8512-bf3d4cc22eb92026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 018714
application number: NDA018714

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208975Biltricide Tablets 600 MG Oral TabletPSNd6791c7c-749a-4595-937b-32229dd599021
198140praziquantel 600 MG Oral TabletPSNd6791c7c-749a-4595-937b-32229dd599021
208975praziquantel 600 MG Oral Tablet [Biltricide]SBDd6791c7c-749a-4595-937b-32229dd599021
198140praziquantel 600 MG Oral TabletSCDd6791c7c-749a-4595-937b-32229dd599021
208975Biltricide 600 MG Oral TabletSYd6791c7c-749a-4595-937b-32229dd599021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-146-01764130146011 in 1 BOTTLEHistorical
76413-146-02764130146022 in 1 BOTTLEHistorical
76413-146-03764130146033 in 1 BOTTLEHistorical
76413-146-04764130146044 in 1 BOTTLEHistorical
76413-146-05764130146055 in 1 BOTTLEHistorical