Ramipril

Product NDC
68258-6023
11-digit product format
682586023
Labeler code
68258
Product ID
68258-6023_1cae4261-d794-41d6-b8b1-1555852cbbbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA077900
Marketing category
ANDA
Marketing start
2008-06-18
Marketing end
0000-00-00
Substance
RAMIPRIL
Active strength
10 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 productproduct68258-6023IInactivated by FDA2026-08-10
excluded packagepackage68258-602368258-6023-9IInactivated by FDA2026-08-10

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 packagepackage68258-6023-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68258-6023-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68258-6023-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68258-6023-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68258-6023-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68258-6023-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68258-6023-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68258-6023-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68258-6023-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68258-6023-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68258-6023-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68258-6023-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68258-6023-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68258-6023-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68258-6023-91332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68258-6023-9fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68258-6023-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68258-6023-9bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68258-6023-98dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68258-6023-9e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68258-6023-99bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68258-6023-9110d247fa046…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
A077900-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18
A077900-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18
A077900-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2008-06-18
A077900-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALAB2008-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077900-001AB
A077900-002AB
A077900-003AB
A077900-004AB

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 UTC2026-02A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18d06236e962d9…

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 UTC2026-02A077900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a7d2f1c-330a-4830-b88b-315f5c1bab6bProduct name120151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4Product name220141218

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-6023-9Ramipril90 in 1 BOTTLECAPSULE901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6023RAMIPRIL CAPSULE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20121005_982d2da3-f58f-4956-a920-e102f118b51c.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILHikma Pharmaceuticals USA Inc.7e9e84f7-ff47-463d-bf47-7a9745960aae2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077900
application number: ANDA077900
RamiprilRAMIPRILExelan Pharmaceuticals, Inc.1e1dfacf-b831-4743-a874-9a5e5ef8a1202021-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077900
application number: ANDA077900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261962ramipril 10 MG Oral CapsulePSN982d2da3-f58f-4956-a920-e102f118b51c1
261962ramipril 10 MG Oral CapsuleSCD982d2da3-f58f-4956-a920-e102f118b51c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6023-96825860230990 in 1 BOTTLEHistorical