Home NDC 68462-947 PROCHLORPERAZINE MALEATE
Product NDC 68462-947
11-digit product format 684620947
Labeler code 68462
Product ID 68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROCHLORPERAZINE MALEATE
Dosage form TABLET
Route ORAL
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA216595
Marketing category ANDA
Marketing start 2025-05-28
Substance PROCHLORPERAZINE MALEATE
Active strength 10 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
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 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 A216595-001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 A216595-002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17
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 2 · 48 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 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216595-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2023-03-17 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216595-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2023-03-17 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROCHLORPERAZINE MALEATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCHLORPERAZINE MALEATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I1T8O1JTL6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198365 Internal RxNorm lookup 312635 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 68462-947-01 PROCHLORPERAZINE MALEATE 100 in 1 BOTTLE TABLET 100 4 68462-947-10 PROCHLORPERAZINE MALEATE 1000 in 1 BOTTLE TABLET 1000 4
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 68462-947-01 68462094701 100 TABLET in 1 BOTTLE (68462-947-01) 100 tablet 2025-05-28 No No Current 68462-947-10 68462094710 1000 TABLET in 1 BOTTLE (68462-947-10) 1000 tablet 2025-05-28 No No Current