Home NDC 14789-901 Procainamide Hydrochloride
Product NDC 14789-901
11-digit product format 147890901
Labeler code 14789
Product ID 14789-901_44fbdf17-cfd1-0076-e063-6394a90abf0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Procainamide Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Nexus Pharmaceuticals LLC
Application ANDA206332
Marketing category ANDA
Marketing start 2007-10-14
Substance PROCAINAMIDE HYDROCHLORIDE
Active strength 100 mg/mL
Pharmacologic classes Antiarrhythmic [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206332-001 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 A206332-002 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206332-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2017-10-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206332-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2017-10-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Procainamide Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCAINAMIDE HYDROCHLORIDE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SI4064O0LX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857886 Internal RxNorm lookup 857962 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 14789-901-10 Procainamide Hydrochloride 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 16 14789-901-10 Procainamide Hydrochloride 10 in 1 CARTON INJECTION 10 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14789-901 PROCAINAMIDE HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC] 14 Current NDC, Legacy NDC, 2 package rows 20241127_d58751df-cd8b-45a6-8a32-af19e747e23a.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 Marketing start Marketing end Sample Exclude flag Status 14789-901-10 14789090110 10 VIAL, MULTI-DOSE in 1 CARTON (14789-901-10) / 10 mL in 1 VIAL, MULTI-DOSE 2007-10-14 0000-00-00 No No Current