VERAPAMIL HYDROCHLORIDE

Product NDC: 0404-9967
11-digit product format: 004049967
Labeler code: 0404
Product ID: 0404-9967_49f23347-cbe5-4dc9-8501-3a4d487c2606
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: verapamil hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA211015
Marketing category: ANDA
Marketing start: 2022-01-10
Substance: VERAPAMIL HYDROCHLORIDE
Active strength: 2.5 mg/mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211015-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-06-18
A211015-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211015-001	AP
A211015-002	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	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211015-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211015-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-06-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A211015-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211015-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211015-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211015-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211015-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211015-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211015-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211015-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211015-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211015-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211015-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211015-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211015-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211015-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211015-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211015-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211015-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211015-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211015-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211015-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211015-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211015-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211015-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211015-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211015-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211015-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211015-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211015-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211015-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: VERAPAMIL HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VERAPAMIL HYDROCHLORIDE	2.5 mg/mL

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
1665061	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
262608c5-843a-4122-b858-5affdc670389	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
0404-9967-04	VERAPAMIL HYDROCHLORIDE	4 mL in 1 VIAL	INJECTION, SOLUTION	4		5
0404-9967-04	VERAPAMIL HYDROCHLORIDE	1 in 1 BAG	INJECTION, SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9967	VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241018_262608c5-843a-4122-b858-5affdc670389.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Somerset Therapeutics, LLC	50131bbc-ad43-4708-946f-e4000828137c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcc46d8-76b0-fbd4-e063-6294a90ad9e6	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	4dcb137e-b01a-eb3a-e063-6294a90aaecc	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	Henry Schein, Inc.	262608c5-843a-4122-b858-5affdc670389	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015 ndc (product): 0404-9967
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	bfc7fa37-1ee3-5eb2-e053-2995a90a5622	2023-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	e99a1aea-cd0a-59cb-e053-2a95a90a1147	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211015 application number: ANDA211015

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
1665061	verapamil HCl 10 MG in 4 ML Injection	PSN	262608c5-843a-4122-b858-5affdc670389	5
1665061	4 ML verapamil hydrochloride 2.5 MG/ML Injection	SCD	262608c5-843a-4122-b858-5affdc670389	5
1665061	verapamil HCl 10 MG per 4 ML Injection	SY	262608c5-843a-4122-b858-5affdc670389	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9967-04	00404996704	1 VIAL in 1 BAG (0404-9967-04) / 4 mL in 1 VIAL	1 vial	2022-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Verapamil Hydrochloride Injection, USP Ampule Single-dose Vial Protect from light. Rx only	Henry Schein, Inc.	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	5