Application 074532

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPTOPRILCAPTOPRILTABLET;ORAL12.5MGNoNo
002CAPTOPRILCAPTOPRILTABLET;ORAL25MGNoNo
003CAPTOPRILCAPTOPRILTABLET;ORAL50MGNoNo
004CAPTOPRILCAPTOPRILTABLET;ORAL100MGNoNo

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
A074532-001CAPTOPRILCAPTOPRIL12.5MGTABLET / ORALAB1997-03-28
A074532-002CAPTOPRILCAPTOPRIL25MGTABLET / ORALAB1997-03-28
A074532-003CAPTOPRILCAPTOPRIL50MGTABLET / ORALAB1997-03-28
A074532-004CAPTOPRILCAPTOPRIL100MGTABLET / ORALAB1997-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074532-001AB
A074532-002AB
A074532-003AB
A074532-004AB

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 UTC2026-02A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074532-001CAPTOPRIL12.5MGTABLET / ORALAB1997-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-002CAPTOPRIL25MGTABLET / ORALAB1997-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-003CAPTOPRIL50MGTABLET / ORALAB1997-03-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-004CAPTOPRIL100MGTABLET / ORALAB1997-03-28d06236e962d9…

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 UTC2026-02A074532-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074532-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074532-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074532-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074532-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074532-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074532-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074532-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074532-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074532-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074532-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074532-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074532-004AB1d06236e962d9…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CaptoprilCAPTOPRILBryant Ranch Prepack563737c5-4d63-4957-8022-e3bc3112dfac2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILBryant Ranch Prepack66604c8e-f6b6-4cf9-9561-f1cb4af0e0d62026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILMajor Pharmaceuticalsa43a5373-ded9-4912-8c98-edaec83528362026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAiPing Pharmaceutical, Inc.3b789f16-b291-4012-be39-af3beec3ff9a2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILSolco Healthcare US, LLC2d3779b0-83d9-4b6f-a043-f7768cd7fce62025-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILMethod Pharmaceuticals LLC1a91ac7f-b75d-d111-e063-6394a90a2a932025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAjanta Pharma USA Inc.1fbc9b28-ff10-4b17-a359-e12b4330747e2025-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILGolden State Medical Supply, Inc.d117c8bd-50a8-7355-e053-2a95a90ac70f2025-11-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILBryant Ranch Prepackccbffd30-4b21-4522-bdb8-abba8d5920172025-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAvKARE3362b7a8-026a-b277-e063-6394a90a9dc62025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILPD-Rx Pharmaceuticals, Inc.65ed6e70-f1ee-437e-965c-d1b1fdadd8322025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILHikma Pharmaceuticals USA Inc.607687f4-63cf-411c-a20b-21d238a6b7a72024-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILAmerican Health Packaging9b54feb0-13cd-46a8-9924-f128803811962024-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
CaptoprilCAPTOPRILCamber Pharmaceuticals, Inc.5b44ab6e-6cd9-4e12-b9be-d2e4d954acb52023-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Captopril
generic name: CAPTOPRIL
captoprilCAPTOPRILAMICI PHARMACEUTICALS LLC1395ba5b-2fc9-41ff-9c43-e0740d781dee2022-09-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: captopril
generic name: CAPTOPRIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-4519CaptoprilCaptoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4520CaptoprilCaptoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-4521CaptoprilCaptoprilNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-175CAPTOPRILCAPTOPRILBlenheim Pharmacal, Inc.ANDACurrent
33261-182CAPTOPRILCAPTORPILAidarex Pharmaceuticals LLCANDACurrent
33261-536CAPTOPRILCAPTORPILAidarex Pharmaceuticals LLCANDACurrent
33261-974CAPTOPRILCAPTORPILAidarex Pharmaceuticals LLCANDACurrent
42254-335CAPTOPRILCAPTORPILRebel Distributors CorpANDACurrent
42254-353CAPTOPRILCAPTORPILRebel Distributors CorpANDACurrent
53217-003CAPTOPRILCAPTOPRILAidarex Pharmaceuticals LLCANDACurrent
55648-902CAPTOPRILCAPTOPRILWockhardt LimitedANDACurrent
55648-903CAPTOPRILCAPTORPILWockhardt LimitedANDACurrent
55648-904CAPTOPRILCAPTORPILWockhardt LimitedANDACurrent
55648-905CAPTOPRILCAPTORPILWockhardt LimitedANDACurrent
57721-902CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-902CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-902CAPTOPRILcaptoprilWindlas Biotech LimitedANDACurrent
57721-903CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-903CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-903CAPTOPRILcaptoprilWindlas Biotech LimitedANDACurrent
57721-904CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-904CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-904CAPTOPRILcaptoprilWindlas Biotech LimitedANDACurrent
57721-905CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-905CAPTOPRILcaptoprilWindlas Healthcare (P) Ltd.ANDACurrent
57721-905CAPTOPRILcaptoprilWindlas Biotech LimitedANDACurrent
63629-2541CaptoprilCaptoprilBryant Ranch PrepackANDACurrent
64679-902CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-902CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-902CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-903CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-903CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-903CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-904CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-904CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-904CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-905CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-905CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
64679-905CAPTOPRILcaptoprilWockhardt USA LLC.ANDACurrent
68645-160CaptoprilCaptoprilLegacy Pharmaceutical PackagingANDACurrent
68645-161CaptoprilCaptoprilLegacy Pharmaceutical PackagingANDACurrent
68645-162CaptoprilCaptoprilLegacy Pharmaceutical PackagingANDACurrent
68645-163CaptoprilCaptoprilLegacy Pharmaceutical PackagingANDACurrent
68788-9721CAPTOPRILcaptoprilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9731CAPTOPRILcaptoprilPreferred Pharmaceuticals, Inc.ANDACurrent
69158-003CAPTOPRILCAPTOPRILGLENVIEW PHARMA INC.ANDACurrent
69158-004CAPTOPRILCAPTOPRILGLENVIEW PHARMA INC.ANDACurrent
69158-005CAPTOPRILCAPTOPRILGLENVIEW PHARMA INC.ANDACurrent