Verapamil Hydrochloride

Product NDC: 48433-145
11-digit product format: 484330145
Labeler code: 48433
Product ID: 48433-145_5127f877-cb34-67de-e063-6294a90abb84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: verapamil hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA075138
Marketing category: ANDA
Marketing start: 2026-05-05
Substance: VERAPAMIL HYDROCHLORIDE
Active strength: 120 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075138-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20
A075138-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20
A075138-003	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075138-001	AB
A075138-002	AB
A075138-003	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 4 · 123 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	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-002	VERAPAMIL HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-003	VERAPAMIL HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075138-001	VERAPAMIL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	1999-04-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A075138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075138-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075138-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075138-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075138-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075138-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075138-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075138-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075138-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075138-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075138-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075138-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075138-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075138-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075138-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075138-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075138-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075138-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075138-001	AB	1	`8072bd15b7f6…`

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	120 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
897612	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
bf7b5037-7355-4788-b17b-323c18a5aee7	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	Strength	SPL version
48433-145-01	Verapamil Hydrochloride	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1		2
48433-145-20	Verapamil Hydrochloride	100 in 1 CARTON	CAPSULE, EXTENDED RELEASE	100		2

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
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Safecor Health LLC	bf7b5037-7355-4788-b17b-323c18a5aee7	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075138 application number: ANDA075138 ndc (product): 48433-145
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Mylan Institutional Inc.	3bee2d26-138c-4641-a217-a38d3d657461	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075138 application number: ANDA075138
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	c86084bc-33aa-eece-5a96-6c0dad2d1a32	2021-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075138 application number: ANDA075138

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897612	verapamil HCl 120 MG 24HR Extended Release Oral Capsule	PSN	bf7b5037-7355-4788-b17b-323c18a5aee7	2
897612	24 HR verapamil hydrochloride 120 MG Extended Release Oral Capsule	SCD	bf7b5037-7355-4788-b17b-323c18a5aee7	2
897612	verapamil hydrochloride 120 MG 24HR Extended Release Oral Capsule	SY	bf7b5037-7355-4788-b17b-323c18a5aee7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-145-01	48433014501	1 in 1 BLISTER PACK					Historical
48433-145-20	48433014520	100 BLISTER PACK in 1 CARTON (48433-145-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-145-01)	100 blister pack	2026-05-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Verapamil Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	3