Home NDC 0409-1902 Procainamide Hydrochloride
Product NDC 0409-1902
11-digit product format 004091902
Labeler code 0409
Product ID 0409-1902_5c75003d-8b7f-4e26-b76e-11a749a53ae6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROCAINAMIDE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
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 2027-12-31
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 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 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 0409-1902-01 Procainamide Hydrochloride 25 in 1 CASE INJECTION, SOLUTION 25 25 0409-1902-11 Procainamide Hydrochloride 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 25 0409-1902-11 Procainamide Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROCAINAMIDE HYDROCHLORIDE ACTIVE INGREDIENT SI4064O0LX PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 PROCAINAMIDE ACTIVE MOIETY L39WTC366D PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 Procainamide Hydrochloride ACTIVE INGREDIENT SI4064O0LX PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Procainamide ACTIVE MOIETY L39WTC366D PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 Sodium Metabisulfite INACTIVE INGREDIENT 4VON5FNS3C PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1902 PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 24 Current NDC, Legacy NDC, 3 package rows 20230629_17e47845-daad-434c-a784-6d3875b0d704.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 ndc (product): 0409-1902 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
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 0409-1902-01 00409190201 25 CARTON in 1 CASE (0409-1902-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1902-11) / 10 mL in 1 VIAL, MULTI-DOSE 25 carton 2006-03-08 0000-00-00 No No Current 0409-1902-11 00409190211 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical