verapamil hydrochloride

Product NDC
71205-017
11-digit product format
712050017
Labeler code
71205
Product ID
71205-017_a56062ad-d6ec-4335-b902-7ac80cecf3d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078906
Marketing category
ANDA
Marketing start
2009-09-17
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
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
verapamil hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE240 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
897649Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1Available 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
71205-017-30verapamil hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
71205-017-60verapamil hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
71205-017-90verapamil hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-017-30EA - Each71205-017034d5fd6-1e53-46f2-94dd-3f8b139f65ec12018-06-11
71205-017-90EA - Each71205-01798dda98a-13d8-4fd2-b7b9-106f46545b0b12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-017VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191101_4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1.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
ndc (product): 71205-017
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
897649verapamil HCl 240 MG Extended Release Oral TabletPSN4ffa579e-1d85-4b3b-ae06-6a9334e0f9e13
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCD4ffa579e-1d85-4b3b-ae06-6a9334e0f9e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-017-307120500173030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-017-30) 2018-04-020000-00-00NoNoCurrent
71205-017-607120500176060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-017-60) 2018-04-020000-00-00NoNoCurrent
71205-017-907120500179090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-017-90) 2018-04-020000-00-00NoNoCurrent