FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
62135-532
11-digit product format
621350532
Labeler code
62135
Product ID
62135-532_3131e786-8a0d-233f-e063-6294a90ac12b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
NDA020943
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1998-11-25
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
100 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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020943-001VERELAN PMVERAPAMIL HYDROCHLORIDE100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25
N020943-002VERELAN PMVERAPAMIL HYDROCHLORIDE200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25
N020943-003VERELAN PMVERAPAMIL HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020943-002VERELAN PM200MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020943-003VERELAN PM300MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS1998-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020943-001VERELAN PM100MGCAPSULE, EXTENDED RELEASE / ORALRLD1998-11-258072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020943-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020943-002AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09N020943-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020943-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020943-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020943-002AB1ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE100 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897584Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
18f6d349-8c5c-4443-ac65-16bf6619ecdcAvailable on FDA.report

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
62135-532-30Verapamil Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-532-30EA - Each62135-53291cbc642-19ff-4c7f-88ec-6e0dd767964e12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-532VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CHARTWELL RX, LLC]3Current NDC, 1 package rows20250327_18f6d349-8c5c-4443-ac65-16bf6619ecdc.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 HYDROCHLORIDEChartwell RX, LLC18f6d349-8c5c-4443-ac65-16bf6619ecdc2025-03-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 020943
application number: NDA020943
ndc (product): 62135-532
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEWilshire Pharmaceuticals, Inc.5f665d08-e1e4-422a-88c2-d8834abf9e1a2024-11-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 020943
application number: NDA020943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897584verapamil HCl 100 MG 24HR Extended Release Oral CapsulePSN18f6d349-8c5c-4443-ac65-16bf6619ecdc3
89758424 HR verapamil hydrochloride 100 MG Extended Release Oral CapsuleSCD18f6d349-8c5c-4443-ac65-16bf6619ecdc3
897584verapamil hydrochloride 100 MG 24 HR Extended Release Oral CapsuleSY18f6d349-8c5c-4443-ac65-16bf6619ecdc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-532-306213505323030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62135-532-30) 2023-03-30NoNoCurrent