CAPTOPRIL

Product NDC
42254-353
11-digit product format
422540353
Labeler code
42254
Product ID
42254-353_851ff660-e6a4-48f8-a6d0-4c10dbb01836
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CAPTORPIL
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074532
Marketing category
ANDA
Marketing start
1997-03-28
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 productproduct42254-353IInactivated by FDA2026-08-07
excluded packagepackage42254-35342254-353-90IInactivated 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 NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-353-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-353-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-353-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-353-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-353-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-353-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-353-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-353-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-353-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-353-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-353-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-353-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-353-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-353-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-353-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-353-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-353-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-353-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-353-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-353-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-353-909bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-353-90110d247fa046…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
42254-353-902019-09-24C16284748780-19350213a-3bf3-c013-e053-90daa90a1393CAPTOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-353-90CAPTOPRIL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-353-90EA - Each42254-3533360789f-20c7-4449-8ba4-05bd1605964112013-02-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-353CAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130213_851ff660-e6a4-48f8-a6d0-4c10dbb01836.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317173captopril 25 MG Oral TabletPSN851ff660-e6a4-48f8-a6d0-4c10dbb018361
308964captopril 50 MG Oral TabletPSN851ff660-e6a4-48f8-a6d0-4c10dbb018361
317173captopril 25 MG Oral TabletSCD851ff660-e6a4-48f8-a6d0-4c10dbb018361
308964captopril 50 MG Oral TabletSCD851ff660-e6a4-48f8-a6d0-4c10dbb018361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-353-904225403539090 in 1 BOTTLEHistorical