Home NDC 0713-0351 Prochlorperazine Edisylate
Product NDC 0713-0351
11-digit product format 007130351
Labeler code 0713
Product ID 0713-0351_284f182c-9dde-805f-e063-6394a90a0f02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prochlorperazine Edisylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA213626
Marketing category ANDA
Marketing start 2022-02-11
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 A213626-001 PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213626-001 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 2026-08-18 06:07:40 2026-07 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213626-001 PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2021-09-28 a50c72e98297…
Observed Orange Book normalized TE history# 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 0713-0351-02 Prochlorperazine Edisylate 2 mL in 1 VIAL INJECTION 2 3 0713-0351-09 Prochlorperazine Edisylate 10 in 1 PACKAGE INJECTION 10 3 0713-0351-25 Prochlorperazine Edisylate 25 in 1 PACKAGE INJECTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0351 PROCHLORPERAZINE EDISYLATE INJECTION [COSETTE PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 3 package rows 20241204_4687b9f5-2d67-4fe0-af4d-2415a42b5292.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 · 1 matching rows.
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 0713-0351-02 00713035102 2 mL in 1 VIAL 2 ml Historical 0713-0351-09 00713035109 10 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02) 10 vial 2022-02-11 0000-00-00 No No Current 0713-0351-25 00713035125 25 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02) 25 vial 2022-02-11 0000-00-00 No No Current