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 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090700-001VERAPAMIL 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…
2021-12-28 21:50 UTC2021-12A090700-001VERAPAMIL HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2011-08-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A090700-002VERAPAMIL HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRS2011-08-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A090700-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090700-002AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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