Verapamil Hydrochloride

Product NDC
51754-0205
11-digit product format
517540205
Labeler code
51754
Product ID
51754-0205_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
2018-06-11
Marketing end
0000-00-00
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51754-0205IInactivated by FDA2026-08-03
excluded packagepackage51754-020551754-0205-2IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51754-0205-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51754-0205-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51754-0205-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51754-0205-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51754-0205-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51754-0205-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51754-0205-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51754-0205-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51754-0205-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-0205-22025-01-30C16284748780-12cef2736-6507-d83d-e063-dadaa90ab31fVerapamil Hydrochloride Injection, USP For Intravenous Injection Protect from light

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-0205-2Verapamil Hydrochloride4 mL in 1 VIALINJECTION46
51754-0205-2Verapamil Hydrochloride5 in 1 CARTONINJECTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0205-2ML - Milliliter51754-02052b576d2d-2700-4d5c-bdb1-0c6edf144d1a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0205VERAPAMIL HYDROCHLORIDE INJECTION [EXELA PHARMA SCIENCES, LLC]6Legacy NDC, 2 package rows20210916_eff5e83b-f819-4a5b-9746-12bce328d7a7.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 · 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): 51754-0205
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEEXELA PHARMA SCIENCES, LLC3318e357-0660-44f4-8170-91a51bd762fb2017-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 018925
application number: NDA018925

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-0205-2517540205025 VIAL in 1 CARTON (51754-0205-2) > 4 mL in 1 VIAL5 vial2018-06-110000-00-00NoNoCurrent