Home NDC 51662-1558 PROCHLORPERAZINE EDISYLATE
Product NDC 51662-1558
11-digit product format 516621558
Labeler code 51662
Product ID 51662-1558_10358f91-4227-7e42-e063-6394a90a62de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROCHLORPERAZINE EDISYLATE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA089903
Marketing category ANDA
Marketing start 2022-06-15
Substance PROCHLORPERAZINE EDISYLATE
Active strength 5 mg/mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089903-001 PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089903-001 AP
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 · 42 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 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROCHLORPERAZINE EDISYLATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCHLORPERAZINE EDISYLATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PG20W5VQZS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2102949 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 51662-1558-2 PROCHLORPERAZINE EDISYLATE 2 mL in 1 VIAL INJECTION 2 2 51662-1558-2 PROCHLORPERAZINE EDISYLATE 1 in 1 POUCH INJECTION 1 2 51662-1558-3 PROCHLORPERAZINE EDISYLATE 25 in 1 CASE INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1558 PROCHLORPERAZINE EDISYLATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 3 package rows 20240228_e181c18d-32a8-587e-e053-2995a90acc5b.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE Hikma Pharmaceuticals USA Inc. baf59816-7577-4652-b065-fb6de9e54569 2025-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089903 application number: ANDA089903 Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE Civica, Inc. e3e0c6c5-6b92-40e0-a926-29c64846be93 2025-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089903 application number: ANDA089903 PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE HF Acquisition Co LLC, DBA HealthFirst e181c18d-32a8-587e-e053-2995a90acc5b 2024-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089903 application number: ANDA089903 ndc (product): 51662-1558
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 51662-1558-2 51662155802 2 mL in 1 VIAL 2 ml Historical 51662-1558-3 51662155803 25 POUCH in 1 CASE (51662-1558-3) / 1 VIAL in 1 POUCH (51662-1558-2) / 2 mL in 1 VIAL 25 pouch 2022-06-15 0000-00-00 No No Current