verapamil hydrochloride

Product NDC: 70518-1326
11-digit product format: 705181326
Labeler code: 70518
Product ID: 70518-1326_521aae97-206d-e408-e063-6294a90a8bc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: verapamil hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078906
Marketing category: ANDA
Marketing start: 2018-07-26
Substance: VERAPAMIL HYDROCHLORIDE
Active strength: 240 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 1.

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
A078906-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078906-001	AB

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 · 41 observed 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	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2009-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078906-001	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB		2009-09-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078906-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078906-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078906-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078906-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078906-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078906-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078906-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078906-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078906-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078906-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078906-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078906-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078906-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078906-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078906-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078906-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078906-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078906-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078906-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078906-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078906-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078906-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078906-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078906-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078906-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078906-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078906-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078906-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078906-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078906-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078906-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078906-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078906-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078906-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078906-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078906-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078906-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078906-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078906-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078906-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: verapamil hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VERAPAMIL HYDROCHLORIDE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V3888OEY5R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897649	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
5dc5f087-c8da-4ed0-b532-ae44508958aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4	Product name	2	20230103
33ad674d-d105-6aa5-02fa-95ae4329b8cd	Product name	2	20180809
3279bd6d-5b02-e60b-3857-c853a2deb2dd	Product name	2	20170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84a	Product name	1	20140508
940a1faa-2df8-cc65-be37-1b97984b4ea3	Product name	1	20140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13	Product name	1	20140508
e2fcd66c-a043-3187-790d-b0342deb1149	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-1326-0	verapamil hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	16
70518-1326-1	verapamil hydrochloride	50 in 1 BOX	TABLET, FILM COATED, EXTENDED RE	50	16
70518-1326-2	verapamil hydrochloride	1 in 1 POUCH	TABLET, FILM COATED, EXTENDED RE	1	16
70518-1326-3	verapamil hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1326	VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 4 package rows	20250511_5dc5f087-c8da-4ed0-b532-ae44508958aa.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	5dc5f087-c8da-4ed0-b532-ae44508958aa	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906 ndc (product): 70518-1326
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3c215e6c-d85a-4102-a1c2-f00fa3169a55	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	62c3aadf-412e-41a5-9e57-2c48d962f90a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	ba1bf1ae-9347-4d17-998b-14bf7b5984ce	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	af1249b0-e889-4f02-bdc2-54862de0545e	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3f14442c-8178-0bad-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Proficient Rx LP	4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906
verapamil hydrochloride	VERAPAMIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c635f442-2349-4820-877a-a42e5f0a44b5	2019-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078906 application number: ANDA078906

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V3888OEY5R	VERAPAMIL HYDROCHLORIDE	152-11-4	VERAPAMIL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1326-0	70518132600	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1326-0)		2018-07-30	0000-00-00	No	No	Current
70518-1326-1	70518132601	50 POUCH in 1 BOX (70518-1326-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-1326-2)	50 pouch	2026-04-27		No	No	Current
70518-1326-2	70518132602	1 in 1 POUCH						Historical
70518-1326-3	70518132603	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1326-3)		2026-05-13		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Verapamil Hydrochloride Extended-Release Tablets, USP	REMEDYREPACK INC.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	17