Home NDC 55154-4183 Prochlorperazine Edisylate
Product NDC 55154-4183
11-digit product format 551544183
Labeler code 55154
Product ID 55154-4183_5ad400a8-04d3-42e7-84b7-b5da30dcb859
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prochlorperazine Edisylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cardinal Health 107, LLC
Application ANDA204147
Marketing category ANDA
Marketing start 2012-03-26
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 A204147-001 PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204147-001 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 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 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 314192 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 55154-4183-5 Prochlorperazine Edisylate 2 mL in 1 VIAL INJECTION 2 11 55154-4183-5 Prochlorperazine Edisylate 5 in 1 BAG INJECTION 5 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-4183 PROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH 107, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240210_6135944c-3ee2-4491-9704-33f56ad435f4.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE Cardinal Health 107, LLC 6135944c-3ee2-4491-9704-33f56ad435f4 2025-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204147 application number: ANDA204147 ndc (product): 55154-4183 Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 0dc48e66-6081-421b-952b-4867c9c4c794 2025-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204147 application number: ANDA204147 prochlorperazine edisylate PROCHLORPERAZINE EDISYLATE Avenacy Inc. fd07a1a3-c0df-4926-9964-07348e45a5fd 2024-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204147 application number: ANDA204147 Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 0338b221-db43-45c9-a829-d970fe6643ab 2024-12-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204147 application number: ANDA204147
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 55154-4183-5 55154418305 5 VIAL in 1 BAG (55154-4183-5) / 2 mL in 1 VIAL 5 vial 2012-03-26 0000-00-00 No No Current