Procainamide Hydrochloride

Product NDC
71872-7170
11-digit product format
718727170
Labeler code
71872
Product ID
71872-7170_8effb720-d9f2-2961-e053-2a95a90ac10f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Procainamide Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA206332
Marketing category
ANDA
Marketing start
2017-10-18
Marketing end
0000-00-00
Substance
PROCAINAMIDE HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7170IInactivated by FDA2026-08-10
excluded packagepackage71872-717071872-7170-1IInactivated by FDA2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71872-7170-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71872-7170-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71872-7170-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71872-7170-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71872-7170-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71872-7170-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71872-7170-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71872-7170-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71872-7170-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71872-7170-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71872-7170-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71872-7170-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71872-7170-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71872-7170-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71872-7170-11332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206332-001PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13
A206332-002PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206332-001AP
A206332-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206332-001PROCAINAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAP2017-10-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A206332-002PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTIONAP2017-10-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206332-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206332-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206332-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206332-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206332-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206332-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206332-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206332-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206332-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206332-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206332-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206332-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206332-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206332-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206332-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206332-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206332-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206332-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206332-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206332-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206332-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206332-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206332-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206332-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206332-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206332-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206332-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206332-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206332-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206332-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206332-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206332-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206332-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206332-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206332-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206332-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206332-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206332-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206332-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206332-002AP1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67853295-be49-b731-d597-94f59291a90cProduct name320250311

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71872-7170-12023-01-30C16284748780-1f386c649-ce5e-0266-e053-dadaa90a7c1aProcainamide Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7170-1Procainamide Hydrochloride1 in 1 BAGINJECTION11
71872-7170-1Procainamide Hydrochloride1 in 1 VIAL, MULTI-DOSEINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7170PROCAINAMIDE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Legacy NDC, 2 package rows20190801_8effb720-d9f1-2961-e053-2a95a90ac10f.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDENexus Pharmaceuticals LLCd58751df-cd8b-45a6-8a32-af19e747e23a2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206332
application number: ANDA206332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857886procainamide HCl 100 MG/ML Injectable SolutionPSN8effb720-d9f1-2961-e053-2a95a90ac10f1
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD8effb720-d9f1-2961-e053-2a95a90ac10f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7170-1718727170011 VIAL, MULTI-DOSE in 1 BAG (71872-7170-1) > 1 INJECTION in 1 VIAL, MULTI-DOSE2019-06-190000-00-00NoNoCurrent