Cardene

Product NDC
68151-0089
11-digit product format
681510089
Labeler code
68151
Product ID
68151-0089_f4b1511d-945c-41fa-8fcf-f30e931526b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nicardipine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020005
Marketing category
NDA
Marketing start
1992-02-21
Marketing end
0000-00-00
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct68151-0089IInactivated by FDA2026-08-17
excluded packagepackage68151-008968151-0089-0DDiscontinued by firm2026-08-17

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 · 34 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 packagepackage68151-0089-0DDiscontinued by firmd630ba8d3edf…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 packagepackage68151-0089-0DDiscontinued by firmf5e01cc5f278…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 packagepackage68151-0089-0DDiscontinued by firm2ef7874e63bc…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 packagepackage68151-0089-0DDiscontinued by firma1b67e2a42f9…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 packagepackage68151-0089-0DDiscontinued by firmcfe11265f3b6…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 packagepackage68151-0089-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-0089-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-0089-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-0089-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-0089-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-0089-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-0089-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020005-001CARDENE SRNICARDIPINE HYDROCHLORIDE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21
N020005-002CARDENE SRNICARDIPINE HYDROCHLORIDE45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21
N020005-003CARDENE SRNICARDIPINE HYDROCHLORIDE60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020005-002CARDENE SR45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020005-003CARDENE SR60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020005-001CARDENE SR30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1992-02-211e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0089-02020-01-31C16284748780-19d75b9d1-27d8-f424-e053-dadaa90a57ceCARDENE SR (nicardipine hydrochloride) SUSTAINED RELEASE CAPSULES ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0089-0Cardene SR1 in 1 PACKAGECAPSULE, EXTENDED RELEASE13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0089CARDENE SR (NICARDIPINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_613c79eb-b34d-4fea-82d0-61b8c4840182.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858589Cardene SR 30 MG 12HR Extended Release Oral CapsulePSN613c79eb-b34d-4fea-82d0-61b8c48401823
858587niCARdipine HCl 30 MG 12HR Extended Release Oral CapsulePSN613c79eb-b34d-4fea-82d0-61b8c48401823
85858912 HR nicardipine hydrochloride 30 MG Extended Release Oral Capsule [Cardene]SBD613c79eb-b34d-4fea-82d0-61b8c48401823
85858712 HR nicardipine hydrochloride 30 MG Extended Release Oral CapsuleSCD613c79eb-b34d-4fea-82d0-61b8c48401823
85858912 HR Cardene 30 MG Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858589Cardene 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858589Cardene SR 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823
858587nicardipine hydrochloride 30 MG 12 HR Extended Release Oral CapsuleSY613c79eb-b34d-4fea-82d0-61b8c48401823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0089-0681510089001 in 1 PACKAGEHistorical