Application 018602

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDIZEMDILTIAZEM HYDROCHLORIDETABLET;ORAL30MGYesNo
002CARDIZEMDILTIAZEM HYDROCHLORIDETABLET;ORAL60MGYesNo
003CARDIZEMDILTIAZEM HYDROCHLORIDETABLET;ORAL90MGYesNo
004CARDIZEMDILTIAZEM HYDROCHLORIDETABLET;ORAL120MGYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018602-001CARDIZEMDILTIAZEM HYDROCHLORIDE30MGTABLET / ORALABRLD1982-11-05
N018602-002CARDIZEMDILTIAZEM HYDROCHLORIDE60MGTABLET / ORALABRLD1982-11-05
N018602-003CARDIZEMDILTIAZEM HYDROCHLORIDE90MGTABLET / ORALABRLD1986-12-08
N018602-004CARDIZEMDILTIAZEM HYDROCHLORIDE120MGTABLET / ORALABRLD, RS1986-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N018602-001AB
N018602-002AB
N018602-003AB
N018602-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018602-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018602-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018602-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-004AB1d06236e962d9…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CardizemDILTIAZEM HYDROCHLORIDEBausch Health US LLCf3e7ecef-f360-4987-a4f5-933214130ab22025-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
ndc (product): 0187-0772
ndc (product): 0187-0792
ndc (product): 0187-0771
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.636556f6-2987-984f-e053-2991aa0a201a2024-06-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
ndc (product): 68071-4242
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack225a87fb-d353-4ee7-bd08-14d631ff6b162023-06-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
ndc (product): 71335-0579
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticalsf6a24de7-8ffe-48af-873f-10fdcd5551d12020-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
ndc (product): 68682-006
ndc (product): 68682-008
ndc (product): 68682-009
ndc (product): 68682-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0771CardizemDiltiazem HydrochlorideBausch Health Americas Inc.NDACurrent
0187-0771CardizemDiltiazem HydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-0771CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0771CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0771CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0771CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0772CardizemDiltiazem HydrochlorideBausch Health Americas Inc.NDACurrent
0187-0772CardizemDiltiazem HydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-0772CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0772CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0772CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0772CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0792CardizemDiltiazem HydrochlorideBausch Health Americas Inc.NDACurrent
0187-0792CardizemDiltiazem HydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-0792CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0792CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0792CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
0187-0792CardizemDiltiazem HydrochlorideBausch Health US LLCNDACurrent
58118-1007Diltiazem HydrochlorideDiltiazem HydrochlorideClinical Solutions Wholesale, LLCNDA AUTHORIZED GENERICCurrent
58118-1007Diltiazem HydrochlorideDiltiazem HydrochlorideClinical Solutions Wholesale, LLCNDA AUTHORIZED GENERICCurrent
58118-1007Diltiazem HydrochlorideDiltiazem HydrochlorideClinical Solutions Wholesale, LLCNDA AUTHORIZED GENERICCurrent
68071-3290Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68071-4242Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-4242Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-4242Diltiazem HydrochlorideDiltiazem HydrochlorideNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68682-006Diltiazem HydrochlorideDiltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-006Diltiazem HydrochlorideDiltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-006Diltiazem HydrochlorideDiltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-006Diltiazem HydrochlorideDiltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-006Diltiazem HydrochlorideDiltiazem hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-007Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-007Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-007Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-007Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-007Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-008Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-008Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-008Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-008Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-008Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-009Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-009Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-009Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-009Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-009Diltiazem HydrochlorideDiltiazem HydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70518-0783Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0783Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1096Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1096Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1096Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1096Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2443Diltiazem HydrochlorideDiltiazem HydrochlorideREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70934-559Diltiazem HydrochlorideDiltiazem HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70934-559Diltiazem HydrochlorideDiltiazem HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
70934-854Diltiazem HydrochlorideDiltiazem HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsNDA AUTHORIZED GENERICCurrent
71335-0579Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0579Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0579Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1001Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1001Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1001Diltiazem HydrochlorideDiltiazem HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81994SUPPL 2025-04-25
81952SUPPL 2025-04-24
64892SUPPL2020-10-13
64884SUPPL2020-10-09
45911SUPPL2016-11-22
45943SUPPL2016-11-21
33511SUPPL2014-11-25
953SUPPL2010-11-30
11243SUPPL2010-11-22