Application 090700

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGNoNo
002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL180MGNoYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090700-001VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03
A090700-002VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090700-001AB
A090700-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03caaa826d4ba7…
2026-08-18 06:07:402026-07A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090700-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090700-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090700-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090700-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090700-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090700-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090700-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090700-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090700-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090700-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090700-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090700-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090700-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090700-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090700-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090700-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090700-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090700-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090700-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090700-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090700-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090700-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090700-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090700-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090700-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090700-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090700-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090700-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090700-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090700-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090700-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090700-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090700-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090700-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090700-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090700-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090700-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090700-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090700-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090700-002AB1bb7c543d1eb4…

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.ce9ab27a-e03b-4e40-a0e0-b586cd75dead2026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
ndc (product): 70518-0605
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEA-S Medication Solutionse07b3574-9259-4f64-a9ae-f4e0e64800b62026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
ndc (product): 50090-1400
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d529fe3-7b5c-4dde-9a8c-440a969df3592026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENorthwind Health Company, LLCf7814f9a-e589-4041-e053-6294a90a29e32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAba1bf1ae-9347-4d17-998b-14bf7b5984ce2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
ndc (product): 68462-292
ndc (product): 68462-293
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.febce7aa-7f5a-e0c1-e053-6394a90aebc42025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.d23c757d-39f8-48c3-ba63-df2cbe58c5162025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
ndc (product): 68788-6328
verapamil hydrochlorideVERAPAMIL HYDROCHLORIDEProficient Rx LP19cb23bd-cc6d-45fc-a1fc-b4130ea460a62019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090700
application number: ANDA090700
ndc (product): 63187-849

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49999-284verapamil hydrochlorideverapamil hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-284verapamil hydrochlorideverapamil hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0584verapamil hydrochlorideverapamil hydrochlorideA-S Medication SolutionsANDACurrent
50090-0584verapamil hydrochlorideverapamil hydrochlorideA-S Medication SolutionsANDACurrent
50090-1400verapamil hydrochlorideverapamil hydrochlorideA-S Medication SolutionsANDACurrent
50090-1400verapamil hydrochlorideverapamil hydrochlorideA-S Medication SolutionsANDACurrent
50090-1400verapamil hydrochlorideverapamil hydrochlorideA-S Medication SolutionsANDACurrent
50436-6916verapamil hydrochlorideverapamil hydrochlorideUnit Dose ServicesANDACurrent
53002-1205verapamil hydrochlorideverapamil hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1205verapamil hydrochlorideverapamil hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1467verapamil hydrochlorideverapamil hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-0936verapamil hydrochlorideverapamil hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55289-607verapamil hydrochlorideverapamil hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
60687-493Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
60687-493Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
60687-493Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
60687-504Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
60687-504Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
60687-504Verapamil HydrochlorideVerapamil HydrochlorideAmerican Health PackagingANDACurrent
63187-849verapamil hydrochlorideverapamil hydrochlorideProficient Rx LPANDACurrent
63187-849verapamil hydrochlorideverapamil hydrochlorideProficient Rx LPANDACurrent
68071-3072verapamil hydrochlorideverapamil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3072verapamil hydrochlorideverapamil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68462-292verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-292verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-292verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-292verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-293verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-293verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-293verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-293verapamil hydrochlorideverapamil hydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6328verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6830verapamil hydrochlorideverapamil hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0605verapamil hydrochlorideverapamil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0605verapamil hydrochlorideverapamil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0605verapamil hydrochlorideverapamil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0605verapamil hydrochlorideverapamil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0605verapamil hydrochlorideverapamil hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-396verapamil hydrochlorideverapamil hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-396verapamil hydrochlorideverapamil hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-902verapamil hydrochlorideverapamil hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0041verapamil hydrochlorideverapamil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0041verapamil hydrochlorideverapamil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0271verapamil hydrochlorideverapamil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0271verapamil hydrochlorideverapamil hydrochlorideBryant Ranch PrepackANDACurrent
71610-258verapamil hydrochlorideverapamil hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent