Application 018925

Type: NDA
Sponsor: EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	5MG/2ML (2.5MG/ML)	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/4ML (2.5MG/ML)	No	No

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
N018925-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		1984-03-30
N018925-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS			2018-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018925-001	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018925-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	1984-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018925-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		2018-04-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018925-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018925-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018925-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018925-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018925-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018925-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018925-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018925-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018925-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018925-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018925-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018925-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018925-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018925-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018925-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018925-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018925-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018925-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018925-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018925-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018925-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018925-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018925-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018925-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018925-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018925-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018925-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018925-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018925-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018925-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018925-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018925-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018925-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018925-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018925-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018925-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018925-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018925-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018925-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018925-001	AP	1	`3f0d92c62455…`

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
VERAPAMIL HCI	VERAPAMIL HCI	HF Acquisition Co LLC, DBA HealthFirst	9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e4	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018925 application number: NDA018925 ndc (product): 51662-1442
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6685248d-908e-cd07-e053-2a91aa0ac718	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018925 application number: NDA018925 ndc (product): 71872-7048
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	EXELA PHARMA SCIENCES, LLC	eff5e83b-f819-4a5b-9746-12bce328d7a7	2017-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018925 application number: NDA018925 ndc (product): 51754-0203 ndc (product): 51754-0205
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	EXELA PHARMA SCIENCES, LLC	3318e357-0660-44f4-8170-91a51bd762fb	2017-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018925 application number: NDA018925 ndc (product): 51754-0204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1442	VERAPAMIL HCI	VERAPAMIL HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1442	VERAPAMIL HCI	VERAPAMIL HCI	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51754-0203	Verapamil Hydrochloride	Verapamil Hydrochloride	EXELA PHARMA SCIENCES, LLC	NDA	Current
51754-0203	Verapamil Hydrochloride	Verapamil Hydrochloride	EXELA PHARMA SCIENCES, LLC	NDA	Current
51754-0204	Verapamil Hydrochloride	Verapamil Hydrochloride	EXELA PHARMA SCIENCES, LLC	NDA	Current
51754-0205	Verapamil Hydrochloride	Verapamil Hydrochloride	EXELA PHARMA SCIENCES, LLC	NDA	Current
51754-0205	Verapamil Hydrochloride	Verapamil Hydrochloride	EXELA PHARMA SCIENCES, LLC	NDA	Current
71872-7048	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current
71872-7048	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45912	SUPPL	2016-11-22
45942	SUPPL	2016-11-21
1128	SUPPL	2011-11-07
11363	SUPPL	2011-11-04
33649	SUPPL	2010-04-19
16097	SUPPL	2010-04-19