Home NDC 72572-580 Prochlorperazine Edisylate
Product NDC 72572-580
11-digit product format 725720580
Labeler code 72572
Product ID 72572-580_7395a535-b3fc-4bb8-b2e1-d8c42b9a0509
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prochlorperazine Edisylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Civica, Inc.
Application ANDA089903
Marketing category ANDA
Marketing start 2019-11-18
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 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.
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 A089903-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 1989-08-29 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 A089903-001 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 · 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 ndc (product): 72572-580 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
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 72572-580-01 Prochlorperazine Edisylate 2 mL in 1 VIAL INJECTION 2 3 72572-580-25 Prochlorperazine Edisylate 25 in 1 CARTON INJECTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72572-580 PROCHLORPERAZINE EDISYLATE INJECTION [CIVICA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250130_e3e0c6c5-6b92-40e0-a926-29c64846be93.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 72572-580-01 72572058001 2 mL in 1 VIAL 2 ml Historical 72572-580-25 72572058025 25 VIAL in 1 CARTON (72572-580-25) / 2 mL in 1 VIAL (72572-580-01) 25 vial 2019-11-18 0000-00-00 No No Current