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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A204147-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP RS 2013-10-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A204147-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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