Home NDC 49884-231 PRAZIQUANTEL
Product NDC 49884-231
11-digit product format 498840231
Labeler code 49884
Product ID 49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRAZIQUANTEL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Endo USA, Inc.
Application ANDA208820
Marketing category ANDA
Marketing start 2017-11-27
Substance PRAZIQUANTEL
Active strength 600 mg/1
Pharmacologic classes Anthelmintic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A208820-001 PRAZIQUANTEL PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27
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 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB RS 2017-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL RS 2017-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB RS 2017-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB RS 2017-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208820-001 PRAZIQUANTEL 600MG TABLET / ORAL AB 2017-11-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base PRAZIQUANTEL
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198140 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 49884-231-83 PRAZIQUANTEL 6 in 1 BOTTLE TABLET, FILM COATED 6 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-231 PRAZIQUANTEL TABLET, FILM COATED [ENDO USA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240926_16f2b9c4-a260-4a31-bd52-e5945913246c.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 49884-231-83 49884023183 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83) 2017-11-27 0000-00-00 No No Current