verapamil hydrochloride

Product NDC
53002-1129
Requested package NDC
53002-1129-0
11-digit product format
530021129
Labeler code
53002
Product ID
53002-1129_5d98215f-216d-4831-bac4-65fa9d65a486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078906
Marketing category
ANDA
Marketing start
2009-09-17
Marketing end
0000-00-00
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 mg/1
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-112953002-1129-0IInactivated by FDA2026-08-07

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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

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
A078906-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078906-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRS2009-09-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078906-001VERAPAMIL HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2009-09-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078906-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078906-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078906-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078906-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078906-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078906-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078906-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078906-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078906-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078906-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078906-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078906-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078906-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078906-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078906-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078906-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078906-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078906-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078906-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078906-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078906-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078906-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078906-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078906-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078906-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078906-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078906-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078906-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078906-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078906-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078906-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078906-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078906-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078906-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078906-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078906-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078906-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078906-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078906-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078906-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1129-0verapamil hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1129VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 1 package rows20230609_b800f810-0a23-4eb0-9ef2-da3979e084a5.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEREMEDYREPACK INC.5dc5f087-c8da-4ed0-b532-ae44508958aa2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c215e6c-d85a-4102-a1c2-f00fa3169a552026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENorthwind Health Company, LLC62c3aadf-412e-41a5-9e57-2c48d962f90a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAba1bf1ae-9347-4d17-998b-14bf7b5984ce2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
Verapamil HydrochlorideVERAPAMIL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.af1249b0-e889-4f02-bdc2-54862de0545e2025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals, Inc.3f14442c-8178-0bad-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP4ffa579e-1d85-4b3b-ae06-6a9334e0f9e12019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc635f442-2349-4820-877a-a42e5f0a44b52019-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078906
application number: ANDA078906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSNb800f810-0a23-4eb0-9ef2-da3979e084a58
897649verapamil HCl 240 MG Extended Release Oral TabletPSNb800f810-0a23-4eb0-9ef2-da3979e084a58
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDb800f810-0a23-4eb0-9ef2-da3979e084a58
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCDb800f810-0a23-4eb0-9ef2-da3979e084a58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1129-053002112900100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-1129-0) 2018-10-010000-00-00NoNoCurrent