CAPTOPRIL

Product NDC
10544-175
11-digit product format
105440175
Labeler code
10544
Product ID
10544-175_9d16dfdc-91bb-49cb-b34b-fe37b0e7faea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAPTOPRIL
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074532
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
CAPTOPRIL
Active strength
50 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-175IInactivated by FDA2026-08-07
excluded packagepackage10544-17510544-175-30IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-175-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-175-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-175-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-175-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-175-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-175-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-175-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-175-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-175-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-175-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-175-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-175-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-175-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-175-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-175-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-175-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-175-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-175-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-175-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-175-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10544-175-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10544-175-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5efca61-58ec-b4d0-77f8-f2b1fb112156Product name420240223

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-175-302020-01-31C16284748780-19d75b9cf-f6bf-f424-e053-dadaa90a57ceCAPTOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-175-30CAPTOPRIL30 in 1 BOTTLETABLET305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-175CAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5Legacy NDC, 1 package rows20151023_bbec074e-04b1-4249-bf3b-85ee8b06c78a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308964captopril 50 MG Oral TabletPSNbbec074e-04b1-4249-bf3b-85ee8b06c78a5
308964captopril 50 MG Oral TabletSCDbbec074e-04b1-4249-bf3b-85ee8b06c78a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-175-301054401753030 in 1 BOTTLEHistorical