Verapamil Hydrochloride

Product NDC
0591-2884
11-digit product format
005912884
Labeler code
0591
Product ID
0591-2884_319554df-fc0d-428a-9799-a352100f1ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Teva Pharmaceuticals Inc
Application
NDA019614
Marketing category
NDA
Marketing start
1990-05-29
Marketing end
2026-07-31
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 mg/1
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
Current FDA listing
Yes

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 productproduct0591-2884DDiscontinued by firm2026-08-03
excluded packagepackage0591-28840591-2884-01DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019614-001VERELANVERAPAMIL HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29
N019614-002VERELANVERAPAMIL HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29
N019614-003VERELANVERAPAMIL HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09
N019614-004VERELANVERAPAMIL HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019614-001AB
N019614-002AB
N019614-003AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019614-001VERELAN120MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019614-002VERELAN240MGCAPSULE, EXTENDED RELEASE / ORALABRLD1990-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019614-003VERELAN180MGCAPSULE, EXTENDED RELEASE / ORALABRLD1992-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N019614-004VERELAN360MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1996-05-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019614-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019614-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019614-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019614-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019614-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019614-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019614-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019614-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019614-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019614-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019614-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019614-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019614-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019614-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019614-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019614-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019614-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019614-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019614-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019614-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019614-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019614-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019614-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019614-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019614-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019614-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0591-2884-01Verapamil Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2884-01EA - Each0591-2884fcee9dff-b569-432c-abfc-6c65b17efab012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2884VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [TEVA PHARMACEUTICALS INC]10Current NDC, Legacy NDC, 1 package rows20221105_0742cf97-601b-4c13-a6c3-1a6a616ed292.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 HYDROCHLORIDEBryant Ranch Prepack522bafc3-4352-4840-b296-e399202c41622025-11-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019614
application number: NDA019614
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDETeva Pharmaceuticals Inc0742cf97-601b-4c13-a6c3-1a6a616ed2922025-09-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 019614
application number: NDA019614
ndc (product): 0591-2884
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEWilshire Pharmaceuticals, Inc.f9399858-fd7a-4b73-8759-3e5bf3af26662024-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 019614
application number: NDA019614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897624verapamil HCl 240 MG 24HR Extended Release Oral CapsulePSN0742cf97-601b-4c13-a6c3-1a6a616ed29211
89762424 HR verapamil hydrochloride 240 MG Extended Release Oral CapsuleSCD0742cf97-601b-4c13-a6c3-1a6a616ed29211
897624verapamil hydrochloride 240 MG 24HR Extended Release Oral CapsuleSY0742cf97-601b-4c13-a6c3-1a6a616ed29211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2884-0100591288401100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2884-01) 1990-05-292026-07-31NoNoCurrent