Ramipril

Product NDC
45865-441
11-digit product format
458650441
Labeler code
45865
Product ID
45865-441_9ab23521-8eee-5740-e053-2a95a90a1411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
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
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-441IInactivated by FDA2026-08-10
excluded packagepackage45865-44145865-441-30IInactivated by FDA2026-08-10
excluded packagepackage45865-44145865-441-49IInactivated 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 · 27 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 packagepackage45865-441-49IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-441-30IInactivated 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 packagepackage45865-441-49IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-441-30IInactivated 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 packagepackage45865-441-49IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-441-30IInactivated 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 packagepackage45865-441-49IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-441-30IInactivated 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 packagepackage45865-441-49IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-441-30IInactivated 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 packagepackage45865-441-49IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-441-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-441-49UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-441-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-441-49UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-441-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-441-49UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-441-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
45865-441-30Ramipril30 in 1 BOTTLECAPSULE302
45865-441-49Ramipril100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-441RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1dc2b41e-97c5-415b-e054-00144ff8d46c.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 CapsulePSN1dc2b41e-97c5-415b-e054-00144ff8d46c2
261962ramipril 10 MG Oral CapsuleSCD1dc2b41e-97c5-415b-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-441-304586504413030 CAPSULE in 1 BOTTLE (45865-441-30) 30 capsule2015-08-260000-00-00NoNoCurrent
45865-441-4945865044149100 CAPSULE in 1 BOTTLE (45865-441-49) 100 capsule2015-08-260000-00-00NoNoCurrent