VERAPAMIL HYDROCHLORIDE

Product NDC: 75834-158
Requested package NDC: 75834-158-01
11-digit product format: 758340158
Labeler code: 75834
Product ID: 75834-158_ebbb0dad-ab4d-4d6c-aebb-d65e2dd08c28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VERAPAMIL HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA206173
Marketing category: ANDA
Marketing start: 2019-05-15
Substance: VERAPAMIL HYDROCHLORIDE
Active strength: 180 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: 2026-12-31
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
A206173-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-05
A206173-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-05
A206173-003	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206173-001	AB
A206173-002	AB
A206173-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206173-001	VERAPAMIL HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206173-002	VERAPAMIL HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-05-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206173-003	VERAPAMIL HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-11-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206173-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206173-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206173-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	e36e485f-fbed-4e30-9a63-984931f2e54e	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173 ndc (package): 75834-158-01 ndc (product): 75834-158 ndc11 (package): 75834015801
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	1de6ad5c-942e-4381-b01f-e5e63bbf72ef	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Cadila Pharmaceuticals Limited	5501208c-aa2b-47aa-89f7-87f4d4a73fd0	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	db990ce1-b193-4a81-e053-2a95a90a627b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Northwind Health Company, LLC	e08c07bf-58b4-6fa2-e053-2a95a90aca32	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	REMEDYREPACK INC.	d7c29dfd-3968-41ac-a081-e670f9bd605c	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b0eeada4-1010-4c11-b408-29f9a1af23c0	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe05b8d8-fdee-903b-e053-6394a90a2e05	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	0b00ec93-0bb3-4181-a6ef-45206f0621f7	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a58f5f77-7e88-d622-e053-2a95a90a0d35	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	f88dfe56-08bc-46b1-8f05-f886a16a89bc	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Bryant Ranch Prepack	2f839b5c-b8e7-40df-887f-7df94326fc7b	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	ed182ebe-8299-4680-9dea-ef79d30db683	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	A-S Medication Solutions	5467dad4-f3ba-4036-b5f4-4d2d4d5abc34	2023-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Proficient Rx LP	343724eb-e80b-4729-80e7-6b8028713ea1	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2712ab16-122b-4f44-a687-e2cb3c04019e	2020-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206173 application number: ANDA206173

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	180 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897640	Internal RxNorm lookup
897649	Internal RxNorm lookup
897659	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
e36e485f-fbed-4e30-9a63-984931f2e54e	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
75834-158-01	VERAPAMIL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		5
75834-158-05	VERAPAMIL HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-158-01	EA - Each	75834-158	c2fdfdd7-675b-42bc-ac5b-552e48bc285e	1	2019-06-19
75834-158-05	EA - Each	75834-158	758236e6-a9bf-4295-982d-456a84b40245	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-158	VERAPAMIL HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20230207_e36e485f-fbed-4e30-9a63-984931f2e54e.zip

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
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	5467dad4-f3ba-4036-b5f4-4d2d4d5abc34	9
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	5467dad4-f3ba-4036-b5f4-4d2d4d5abc34	9
897659	verapamil HCl 120 MG Extended Release Oral Tablet	PSN	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	1de6ad5c-942e-4381-b01f-e5e63bbf72ef	5
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	db990ce1-b193-4a81-e053-2a95a90a627b	5
897649	verapamil HCl 240 MG Extended Release Oral Tablet	PSN	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897659	verapamil hydrochloride 120 MG Extended Release Oral Tablet	SCD	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	1de6ad5c-942e-4381-b01f-e5e63bbf72ef	5
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	db990ce1-b193-4a81-e053-2a95a90a627b	5
897649	verapamil hydrochloride 240 MG Extended Release Oral Tablet	SCD	e36e485f-fbed-4e30-9a63-984931f2e54e	5
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	a58f5f77-7e88-d622-e053-2a95a90a0d35	3
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	a58f5f77-7e88-d622-e053-2a95a90a0d35	3
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	343724eb-e80b-4729-80e7-6b8028713ea1	2
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	343724eb-e80b-4729-80e7-6b8028713ea1	2
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	fdb7cd57-d33c-f5a3-e053-6294a90aff31	2
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	d7c29dfd-3968-41ac-a081-e670f9bd605c	1
897640	verapamil HCl 180 MG Extended Release Oral Tablet	PSN	2712ab16-122b-4f44-a687-e2cb3c04019e	1
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	d7c29dfd-3968-41ac-a081-e670f9bd605c	1
897640	verapamil hydrochloride 180 MG Extended Release Oral Tablet	SCD	2712ab16-122b-4f44-a687-e2cb3c04019e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-158-01	75834015801	100 TABLET in 1 BOTTLE (75834-158-01)	100 tablet	2019-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets	Nivagen Pharmaceuticals, Inc.	2026-05-13	Human Prescription Drug Label	6
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP	Bryant Ranch Prepack	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	5
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets	REMEDYREPACK INC.	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	1
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets	NuCare Pharmaceuticals,Inc.	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	2
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets	A-S Medication Solutions	2023-06-12	Human Prescription Drug Label	9
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP	Proficient Rx LP	2023-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-09-29	HUMAN PRESCRIPTION DRUG LABEL	1
VERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP	Aphena Pharma Solutions - Tennessee, LLC	2020-04-09	HUMAN PRESCRIPTION DRUG LABEL	1