Home NDC 72205-055 pimavanserin
Product NDC 72205-055
11-digit product format 722050055
Labeler code 72205
Product ID 72205-055_403b6540-c53d-4e92-91b4-36ca6338b2b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pimavanserin
Dosage form CAPSULE
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA214925
Marketing category ANDA
Marketing start 2024-01-16
Substance PIMAVANSERIN TARTRATE
Active strength 34 mg/1
Pharmacologic classes Atypical Antipsychotic [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 43 .
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 A214925-001 PIMAVANSERIN PIMAVANSERIN TARTRATE EQ 34MG BASE CAPSULE / ORAL 2024-01-16
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.
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 2026-09-14 22:38:34 2026-08 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL AB 2024-01-16 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214925-001 PIMAVANSERIN EQ 34MG BASE CAPSULE / ORAL 2024-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2024-02-18 07:12 UTC 2024-02 A214925-001 AB 1 1c564ffb4f44…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base pimavanserin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIMAVANSERIN TARTRATE 34 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NA83F1SJSR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049275 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 72205-055-30 pimavanserin 30 in 1 BOTTLE CAPSULE 30 1
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 Status 72205-055-30 72205005530 30 in 1 BOTTLE Historical