Home NDC 49884-348 Pimozide
Product NDC 49884-348
11-digit product format 498840348
Labeler code 49884
Product ID 49884-348_a3c5958c-a773-4d10-ae80-9cd453bf07fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pimozide
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Application ANDA204521
Marketing category ANDA
Marketing start 2015-09-28
Substance PIMOZIDE
Active strength 2 mg/1
Pharmacologic classes Typical Antipsychotic [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 43 .
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 A204521-001 PIMOZIDE PIMOZIDE 1MG TABLET / ORAL AB 2015-09-28 A204521-002 PIMOZIDE PIMOZIDE 2MG TABLET / ORAL AB RS 2015-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 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 2026-09-14 22:38:34 2026-08 A204521-001 PIMOZIDE 1MG TABLET / ORAL AB 2015-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204521-002 PIMOZIDE 2MG TABLET / ORAL AB RS 2015-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204521-001 PIMOZIDE 1MG TABLET / ORAL AB 2015-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204521-002 PIMOZIDE 2MG TABLET / ORAL AB RS 2015-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204521-001 PIMOZIDE 1MG TABLET / ORAL 2015-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204521-002 PIMOZIDE 2MG TABLET / ORAL RS 2015-09-28 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 Pimozide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIMOZIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1HIZ4DL86F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198103 Internal RxNorm lookup 312439 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 49884-348-01 Pimozide 100 in 1 BOTTLE TABLET 100 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PIMOZIDE ACTIVE INGREDIENT 1HIZ4DL86F PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1 PIMOZIDE ACTIVE MOIETY 1HIZ4DL86F PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PIMOZIDE TABLET [PAR PHARMACEUTICAL COMPANIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-348 PIMOZIDE TABLET [ENDO USA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240926_70b079e2-a1f7-4a93-8685-d60a4d7c1280.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 Units Marketing start Marketing end Sample Exclude flag Status 49884-348-01 49884034801 100 TABLET in 1 BOTTLE (49884-348-01) 100 tablet 2015-09-28 0000-00-00 No No Current