Home NDC 54092-546 MOTEGRITY
Product NDC 54092-546
11-digit product format 540920546
Labeler code 54092
Product ID 54092-546_1278ace1-66f8-4bd8-8cf0-bd731f936563
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PRUCALOPRIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA210166
Marketing category NDA
Marketing start 2018-12-14
Substance PRUCALOPRIDE SUCCINATE
Active strength 1 mg/1
Pharmacologic classes Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [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 42 .
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 N210166-001 MOTEGRITY PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 N210166-002 MOTEGRITY PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210166-001 M-14 2028-07-10 N210166-002 M-14 2028-07-10
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 · 84 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 2026-08-18 06:07:40 2026-07 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL AB RLD 2018-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL AB RLD, RS 2018-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210166-001 MOTEGRITY EQ 1MG BASE TABLET / ORAL RLD 2018-12-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210166-002 MOTEGRITY EQ 2MG BASE TABLET / ORAL RLD, RS 2018-12-14 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 56 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MOTEGRITY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRUCALOPRIDE SUCCINATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4V2G75E1CK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2107345 Internal RxNorm lookup 2107351 Internal RxNorm lookup 2107353 Internal RxNorm lookup 2107355 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 54092-546-01 MOTEGRITY 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54092-546 MOTEGRITY (PRUCALOPRIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20250311_bca1e4c6-4b2b-4876-8ab3-654629c4ff1b.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 54092-546-01 54092054601 30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01) 2018-12-14 0000-00-00 No No Current