Home NDC 51662-1630 PROCAINAMIDE HYDROCHLORIDE
Product NDC 51662-1630
11-digit product format 516621630
Labeler code 51662
Product ID 51662-1630_39ae5dd3-dcaa-d40f-e063-6294a90a78af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROCAINAMIDE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA088636
Marketing category ANDA
Marketing start 2023-06-23
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 A088636-001 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088636-001 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 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088636-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 1984-07-31 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 2027-12-31 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 1862220 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 51662-1630-1 PROCAINAMIDE HYDROCHLORIDE 10 mL in 1 SYRINGE INJECTION 10 4 51662-1630-2 PROCAINAMIDE HYDROCHLORIDE 1 in 1 BOX INJECTION 1 4 51662-1630-2 PROCAINAMIDE HYDROCHLORIDE 1 in 1 POUCH INJECTION 1 4 51662-1630-3 PROCAINAMIDE HYDROCHLORIDE 5 in 1 CASE INJECTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1630 PROCAINAMIDE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, 4 package rows 20240123_fece65c0-fdbc-61d8-e053-6294a90a9a68.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst fece65c0-fdbc-61d8-e053-6294a90a9a68 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088636 application number: ANDA088636 ndc (product): 51662-1630 Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE REMEDYREPACK INC. 1ec3b767-66bb-4634-877e-71f70d501da0 2025-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088636 application number: ANDA088636 Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE ProPharma Distribution 3d5d9d6e-1f1c-7565-e063-6394a90a93e7 2025-08-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088636 application number: ANDA088636 Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE International Medication Systems, Limited d7cb1594-61cf-41c4-9007-1ee28aa69c50 2016-12-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088636 application number: ANDA088636
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51662-1630-1 51662163001 10 mL in 1 SYRINGE 10 ml Historical 51662-1630-2 51662163002 1 in 1 BOX Historical 51662-1630-3 51662163003 5 POUCH in 1 CASE (51662-1630-3) / 1 BOX in 1 POUCH (51662-1630-2) / 1 SYRINGE in 1 BOX / 10 mL in 1 SYRINGE (51662-1630-1) 5 pouch 2023-06-23 No No Current