PROCAINAMIDE HYDROCHLORIDE

Product NDC: 51662-1630
Requested package NDC: 51662-1630-3
11-digit product format: 516621630
Labeler code: 51662
Product ID: 51662-1630_54a2bc8f-12bf-562b-e063-6394a90a28e2
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: 2027-12-31
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 · 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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088636-001	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	1984-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088636-001	PROCAINAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	1984-07-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A088636-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088636-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088636-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088636-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088636-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088636-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088636-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088636-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088636-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088636-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088636-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088636-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088636-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088636-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088636-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088636-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088636-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088636-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088636-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088636-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088636-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088636-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088636-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088636-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088636-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088636-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088636-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088636-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088636-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088636-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088636-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088636-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088636-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088636-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088636-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088636-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088636-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088636-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088636-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088636-001	AP	1	`f41ea6bd6efb…`

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: 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fece65c0-fdbc-61d8-e053-6294a90a9a68	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	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	REMEDYREPACK INC.	1ec3b767-66bb-4634-877e-71f70d501da0	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088636 application number: ANDA088636
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 (package): 51662-1630-3 ndc (product): 51662-1630 ndc11 (package): 51662163003
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

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
1862220	procainamide HCl 1000 MG in 10 ML Prefilled Syringe	PSN	fece65c0-fdbc-61d8-e053-6294a90a9a68	4
1862220	10 ML procainamide hydrochloride 100 MG/ML Prefilled Syringe	SCD	fece65c0-fdbc-61d8-e053-6294a90a9a68	4
1862220	procainamide HCl 1000 MG per 10 ML Prefilled Syringe	SY	fece65c0-fdbc-61d8-e053-6294a90a9a68	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCAINAMIDE HYDROCHLORIDE INJ, USP 100MG/ML 10ML SYR	HF Acquisition Co LLC, DBA HealthFirst	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	5