Ramipril

Product NDC
68001-141
11-digit product format
680010141
Labeler code
68001
Product ID
68001-141_c4f8ab80-6693-8a4d-e053-2a95a90ac3a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078832
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
2021-09-30
Substance
RAMIPRIL
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68001-141DDiscontinued by firm2026-08-10
excluded packagepackage68001-14168001-141-00DDiscontinued by firm2026-08-10
excluded packagepackage68001-14168001-141-03DDiscontinued by firm2026-08-10

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 · 36 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 packagepackage68001-141-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-141-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-141-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-141-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-141-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-141-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-141-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-141-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-141-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-141-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-141-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-141-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-141-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-141-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-141-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-141-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-141-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-141-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-141-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-141-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-141-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-141-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-141-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-141-00557ba5c1ecfa…9c80585c8c6e…

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
A078832-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02
A078832-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02
A078832-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2008-09-02
A078832-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALAB2008-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078832-001AB
A078832-002AB
A078832-003AB
A078832-004AB

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 UTC2026-02A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078832-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-003RAMIPRIL5MGCAPSULE / ORALAB2008-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-004RAMIPRIL10MGCAPSULE / ORALAB2008-09-02d06236e962d9…

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 UTC2026-02A078832-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078832-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078832-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078832-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078832-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078832-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078832-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078832-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078832-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078832-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078832-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078832-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078832-004AB1d06236e962d9…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]4
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILZydus Pharmaceuticals USA Inc.055bb582-67cd-425a-8823-d543c14305ce2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078832
application number: ANDA078832
RamiprilRAMIPRILPD-Rx Pharmaceuticals, Inc.6187971a-2756-4791-8801-211bec0a67182025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078832
application number: ANDA078832
RamiprilRAMIPRILZydus Lifesciences Limited496b346b-ca79-4483-a950-bed9464e6a9d2024-12-04Exact identifier
application applno (ANDA): 078832
application number: ANDA078832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-141-0068001014100100 CAPSULE in 1 BOTTLE (68001-141-00) 100 capsule2014-01-012021-09-30NoNoCurrent
68001-141-0368001014103500 CAPSULE in 1 BOTTLE (68001-141-03) 500 capsule2014-01-012021-09-30NoNoCurrent