Home NDC 68083-604 Procainamide Hydrochloride
Product NDC 68083-604
11-digit product format 680830604
Labeler code 68083
Product ID 68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Procainamide Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218135
Marketing category ANDA
Marketing start 2024-07-22
Substance PROCAINAMIDE HYDROCHLORIDE
Active strength 500 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 A218135-001 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 2024-07-22 A218135-002 PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP RS 2024-07-22
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.
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 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP RS 2024-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP 2024-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP 2024-07-22 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218135-001 PROCAINAMIDE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION AP RS 2024-07-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218135-002 PROCAINAMIDE HYDROCHLORIDE 500MG/ML INJECTABLE / INJECTION AP RS 2024-07-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 500 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 68083-604-25 Procainamide Hydrochloride 25 in 1 CASE INJECTION, SOLUTION 25 3 68083-604-25 Procainamide Hydrochloride 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-604 PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 3 Current NDC, 2 package rows 20240730_ffde440f-7ad7-434c-bcd2-9bd8ff16d204.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68083-604-25 68083060425 25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE 2024-07-22 No No Current