Procainamide Hydrochloride

Product NDC: 68083-604
Requested package NDC: 68083-604-25
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 43.

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.

Application-product, TE code table
Application-product	TE code
A218135-001	AP
A218135-002	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.

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
2026-09-14 22:38:34	2026-08	A218135-001	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS	2024-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218135-002	PROCAINAMIDE HYDROCHLORIDE	500MG/ML	INJECTABLE / INJECTION	AP	RS	2024-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218135-001	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RS	2024-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218135-002	PROCAINAMIDE HYDROCHLORIDE	500MG/ML	INJECTABLE / INJECTION	AP	RS	2024-07-22	`caaa826d4ba7…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218135-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218135-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218135-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218135-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218135-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218135-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218135-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218135-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218135-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218135-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218135-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218135-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218135-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218135-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218135-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218135-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218135-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218135-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218135-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218135-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218135-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218135-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218135-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218135-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218135-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218135-002	AP	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218135-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218135-002	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ffde440f-7ad7-434c-bcd2-9bd8ff16d204	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
67853295-be49-b731-d597-94f59291a90c	Product name	3	20250311

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Medical Purchasing Solutions, LLC.	42405567-3d04-7aec-e063-6294a90aba0a	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218135 application number: ANDA218135
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Sagent Pharmaceuticals	358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218135 application number: ANDA218135
Procainamide Hydrochloride	PROCAINAMIDE HYDROCHLORIDE	Gland Pharma Limited	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218135 application number: ANDA218135 ndc (package): 68083-604-25 ndc (product): 68083-604 ndc11 (package): 68083060425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SI4064O0LX	PROCAINAMIDE HYDROCHLORIDE	614-39-1	PROCAINAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857886	procainamide HCl 100 MG/ML Injectable Solution	PSN	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	3
857962	procainamide HCl 500 MG/ML Injectable Solution	PSN	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	3
857886	procainamide hydrochloride 100 MG/ML Injectable Solution	SCD	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	3
857962	procainamide hydrochloride 500 MG/ML Injectable Solution	SCD	ffde440f-7ad7-434c-bcd2-9bd8ff16d204	3

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Procainamide Hydrochloride Injection, USP Multiple-dose Fliptop Vial Rx only	Gland Pharma Limited	2024-07-23	Human Prescription Drug Label	3