Home NDC 70954-853-10 Pimozide
Product NDC 70954-853
Requested package NDC 70954-853-10
11-digit product format 709540853
Labeler code 70954
Product ID 70954-853_e4238455-9da3-4d89-a9ac-254292b9bf15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pimozide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219897
Marketing category ANDA
Marketing start 2026-04-21
Substance PIMOZIDE
Active strength 1 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 A219897-001 PIMOZIDE PIMOZIDE 1MG TABLET / ORAL AB 2026-04-13 A219897-002 PIMOZIDE PIMOZIDE 2MG TABLET / ORAL AB 2026-04-13
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 A219897-001 CGT 2026-10-18 A219897-002 CGT 2026-10-18
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 A219897-001 PIMOZIDE 1MG TABLET / ORAL AB 2026-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219897-002 PIMOZIDE 2MG TABLET / ORAL AB 2026-04-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219897-001 PIMOZIDE 1MG TABLET / ORAL AB 2026-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219897-002 PIMOZIDE 2MG TABLET / ORAL AB 2026-04-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219897-001 PIMOZIDE 1MG TABLET / ORAL AB 2026-04-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219897-002 PIMOZIDE 2MG TABLET / ORAL AB 2026-04-13 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A219897-001 CGT 2026-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219897-002 CGT 2026-10-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219897-001 CGT 2026-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219897-002 CGT 2026-10-18 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219897-001 CGT 2026-10-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219897-002 CGT 2026-10-18 a50c72e98297…
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 1 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 70954-853-10 Pimozide 100 in 1 BOTTLE TABLET 100 2
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 Sample Exclude flag Status 70954-853-10 70954085310 100 TABLET in 1 BOTTLE (70954-853-10) 100 tablet 2026-04-21 No No Current