Verapamil Hydrochloride

Product NDC
51754-0203
11-digit product format
517540203
Labeler code
51754
Product ID
51754-0203_d053ac54-7922-4e79-a5a2-62eb3c2c3f4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
EXELA PHARMA SCIENCES, LLC
Application
NDA018925
Marketing category
NDA
Marketing start
2016-04-22
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
N018925-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30
N018925-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018925-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP2018-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018925-001VERAPAMIL HYDROCHLORIDE5MG/2ML (2.5MG/ML)SOLUTION / INTRAVENOUSAP1984-03-30782e0a99824c…
2021-12-28 21:50 UTC2021-12N018925-002VERAPAMIL HYDROCHLORIDE10MG/4ML (2.5MG/ML)SOLUTION / INTRAVENOUS2018-04-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018925-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018925-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018925-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018925-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018925-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018925-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018925-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018925-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018925-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018925-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018925-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018925-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018925-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018925-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018925-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018925-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018925-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018925-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018925-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018925-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018925-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018925-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018925-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018925-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018925-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018925-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018925-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018925-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N018925-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018925-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N018925-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018925-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N018925-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018925-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018925-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018925-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018925-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018925-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018925-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018925-001AP13f0d92c62455…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERAPAMIL HCIVERAPAMIL HCIHF Acquisition Co LLC, DBA HealthFirst9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e42024-02-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 018925
application number: NDA018925
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEMedical Purchasing Solutions, LLC6685248d-908e-cd07-e053-2a91aa0ac7182023-05-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018925
application number: NDA018925
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEEXELA PHARMA SCIENCES, LLCeff5e83b-f819-4a5b-9746-12bce328d7a72017-02-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 018925
application number: NDA018925
ndc (product): 51754-0203
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEEXELA PHARMA SCIENCES, LLC3318e357-0660-44f4-8170-91a51bd762fb2017-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 018925
application number: NDA018925

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
eff5e83b-f819-4a5b-9746-12bce328d7a7Available 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
51754-0203-2Verapamil Hydrochloride5 in 1 CARTONINJECTION56
51754-0203-2Verapamil Hydrochloride2 mL in 1 VIALINJECTION26
51754-0203-4Verapamil Hydrochloride2 mL in 1 VIALINJECTION26
51754-0203-4Verapamil Hydrochloride25 in 1 CARTONINJECTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0203-2ML - Milliliter51754-02036837256c-fac0-4f0e-af50-1db7c052219212016-05-16
51754-0203-4ML - Milliliter51754-02034d063d90-d6e2-44da-bd9b-e92b5ae3fcd312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0203VERAPAMIL HYDROCHLORIDE INJECTION [EXELA PHARMA SCIENCES, LLC]6Current NDC, Legacy NDC, 4 package rows20210916_eff5e83b-f819-4a5b-9746-12bce328d7a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG in 2 ML InjectionPSNeff5e83b-f819-4a5b-9746-12bce328d7a76
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeff5e83b-f819-4a5b-9746-12bce328d7a76
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeff5e83b-f819-4a5b-9746-12bce328d7a76
1665061verapamil HCl 10 MG per 4 ML InjectionSYeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG per 2 ML InjectionSYeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG in 2 ML InjectionPSN6685248d-908e-cd07-e053-2a91aa0ac7183
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD6685248d-908e-cd07-e053-2a91aa0ac7183
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43
1665057verapamil HCl 5 MG per 2 ML InjectionSY6685248d-908e-cd07-e053-2a91aa0ac7183
1665057verapamil HCl 5 MG per 2 ML InjectionSY9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-0203-2517540203025 VIAL in 1 CARTON (51754-0203-2) / 2 mL in 1 VIAL5 vial2016-04-220000-00-00NoNoCurrent
51754-0203-45175402030425 VIAL in 1 CARTON (51754-0203-4) / 2 mL in 1 VIAL25 vial2016-12-090000-00-00NoNoCurrent