Home NDC 71872-7113 Procainamide Hydrochloride
Product NDC 71872-7113
11-digit product format 718727113
Labeler code 71872
Product ID 71872-7113_0aac32fa-37b8-5520-e063-6394a90a1fe4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROCAINAMIDE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC
Application ANDA089069
Marketing category ANDA
Marketing start 2006-03-08
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089069-001 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1986-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089069-001 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 · 41 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 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1986-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089069-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 1986-02-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857886 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 71872-7113-1 Procainamide Hydrochloride 1 in 1 BAG INJECTION, SOLUTION 1 1 71872-7113-1 Procainamide Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71872-7113 PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] 1 Current NDC, 2 package rows 20231122_0aac32fa-37b7-5520-e063-6394a90a1fe4.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE Hospira, Inc. 17e47845-daad-434c-a784-6d3875b0d704 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089069 application number: ANDA089069 PROCAINAMIDE HCI PROCAINAMIDE HCI HF Acquisition Co LLC, DBA HealthFirst 8192d79d-da2b-2532-e053-2991aa0ae8ad 2024-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089069 application number: ANDA089069 Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE Medical Purchasing Solutions, LLC 0aac32fa-37b7-5520-e063-6394a90a1fe4 2023-11-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089069 application number: ANDA089069 ndc (product): 71872-7113
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71872-7113-1 71872711301 1 CARTON in 1 BAG (71872-7113-1) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE 1 carton 2023-09-12 No No Current