Verapamil Hydrochloride

Product NDC
65145-114
11-digit product format
651450114
Labeler code
65145
Product ID
65145-114_fb2643f1-42d0-410c-a4ab-b0a8ce457cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA213232
Marketing category
ANDA
Marketing start
2025-01-16
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213232-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25
A213232-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213232-001AP
A213232-002AP

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213232-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213232-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2020-03-2587673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213232-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213232-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213232-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213232-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213232-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213232-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213232-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213232-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213232-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213232-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213232-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213232-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213232-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213232-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213232-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213232-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213232-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213232-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213232-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213232-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213232-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213232-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213232-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213232-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213232-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213232-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213232-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213232-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213232-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213232-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213232-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213232-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213232-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213232-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213232-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213232-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213232-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213232-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213232-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213232-002AP187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Verapamil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V3888OEY5RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665057Internal RxNorm lookup
1665061Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e18cc04c-a808-4d92-9b66-762cd787abc5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4Product name220230103
33ad674d-d105-6aa5-02fa-95ae4329b8cdProduct name220180809
3279bd6d-5b02-e60b-3857-c853a2deb2ddProduct name220170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84aProduct name120140508
940a1faa-2df8-cc65-be37-1b97984b4ea3Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65145-114-01Verapamil Hydrochloride4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION45
65145-114-05Verapamil Hydrochloride5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-114VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250117_e18cc04c-a808-4d92-9b66-762cd787abc5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.d7a749d0-4ab3-4fbb-8d7b-e09d68413c412025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213232
application number: ANDA213232
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDECaplin Steriles Limitede18cc04c-a808-4d92-9b66-762cd787abc52025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213232
application number: ANDA213232
ndc (product): 65145-114
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEBaxter Healthcare Corporation03c5daf8-5399-4d89-a747-9a9d7667b6e42020-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213232
application number: ANDA213232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNe18cc04c-a808-4d92-9b66-762cd787abc55
1665057verapamil HCl 5 MG in 2 ML InjectionPSNe18cc04c-a808-4d92-9b66-762cd787abc55
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDe18cc04c-a808-4d92-9b66-762cd787abc55
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDe18cc04c-a808-4d92-9b66-762cd787abc55
1665061verapamil HCl 10 MG per 4 ML InjectionSYe18cc04c-a808-4d92-9b66-762cd787abc55
1665057verapamil HCl 5 MG per 2 ML InjectionSYe18cc04c-a808-4d92-9b66-762cd787abc55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-114-01651450114014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
65145-114-05651450114055 VIAL, SINGLE-DOSE in 1 CARTON (65145-114-05) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-114-01) 2025-01-160000-00-00NoNoCurrent