Verapamil Hydrochloride

Product NDC
25021-312
11-digit product format
250210312
Labeler code
25021
Product ID
25021-312_b4eb5dd2-5e25-4ecc-ac57-8897f2b6984a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214361
Marketing category
ANDA
Marketing start
2021-03-15
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214361-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214361-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-158869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214361-001VERAPAMIL HYDROCHLORIDE2.5MG/MLINJECTABLE / INJECTIONAP2020-10-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214361-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214361-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214361-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214361-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214361-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214361-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214361-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214361-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214361-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214361-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214361-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214361-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214361-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214361-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214361-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214361-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214361-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214361-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214361-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214361-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214361-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A214361-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A214361-001AP18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214361-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214361-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214361-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214361-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214361-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214361-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214361-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214361-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214361-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214361-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214361-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214361-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214361-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214361-001AP1a50c72e98297…

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
a76b2cff-7029-4607-88db-9921ec2842b6Available 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
25021-312-02Verapamil Hydrochloride25 in 1 CARTONINJECTION, SOLUTION252
25021-312-02Verapamil Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION22
25021-312-04Verapamil Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION42
25021-312-04Verapamil Hydrochloride5 in 1 CARTONINJECTION, SOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-312-02ML - Milliliter25021-3123664dbd7-d97f-4203-b5a1-61c385be42ba12021-05-05
25021-312-04ML - Milliliter25021-312049754a5-5743-4b9b-b840-af63ed83022c12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-312VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]2Current NDC, Legacy NDC, 4 package rows20230502_a76b2cff-7029-4607-88db-9921ec2842b6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDESagent Pharmaceuticalsa76b2cff-7029-4607-88db-9921ec2842b62023-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214361
application number: ANDA214361
ndc (product): 25021-312
Verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEGland Pharma Limitedeb3c66f6-581f-422b-9ca2-9b877b323a332020-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214361
application number: ANDA214361

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNa76b2cff-7029-4607-88db-9921ec2842b62
1665057verapamil HCl 5 MG in 2 ML InjectionPSNa76b2cff-7029-4607-88db-9921ec2842b62
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDa76b2cff-7029-4607-88db-9921ec2842b62
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDa76b2cff-7029-4607-88db-9921ec2842b62
1665061verapamil HCl 10 MG per 4 ML InjectionSYa76b2cff-7029-4607-88db-9921ec2842b62
1665057verapamil HCl 5 MG per 2 ML InjectionSYa76b2cff-7029-4607-88db-9921ec2842b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-312-022502103120225 VIAL in 1 CARTON (25021-312-02) / 2 mL in 1 VIAL25 vial2021-03-150000-00-00NoNoCurrent
25021-312-04250210312045 VIAL in 1 CARTON (25021-312-04) / 4 mL in 1 VIAL5 vial2021-03-150000-00-00NoNoCurrent