Ramipril

Product NDC
63187-854
Requested package NDC
63187-854-60
11-digit product format
631870854
Labeler code
63187
Product ID
63187-854_45fcab03-1ec7-4695-b4b7-e4866de4a8c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076549
Marketing category
ANDA
Marketing start
2007-12-26
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-85463187-854-60DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-85463187-854-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-85463187-854-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A076549-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24
A076549-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24
A076549-003RAMIPRILRAMIPRIL5MGCAPSULE / ORAL2005-10-24
A076549-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALAB2005-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076549-001AB
A076549-002AB
A076549-004AB

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 UTC2026-02A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076549-001RAMIPRIL1.25MGCAPSULE / ORALAB2005-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076549-002RAMIPRIL2.5MGCAPSULE / ORALAB2005-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076549-003RAMIPRIL5MGCAPSULE / ORAL2005-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076549-004RAMIPRIL10MGCAPSULE / ORALAB2005-10-24d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076549-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076549-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076549-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076549-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076549-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076549-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076549-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076549-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076549-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076549-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076549-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076549-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076549-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076549-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076549-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076549-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076549-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076549-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076549-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076549-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076549-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076549-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076549-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076549-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076549-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076549-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-854-30EA - Each63187-854779a425a-cd0d-4029-87a2-64cff251bde212018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-854RAMIPRIL CAPSULE [PROFICIENT RX LP]3Legacy NDC20191113_389c415f-5cfb-4ae3-b596-2697af10a166.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-854-606318708546060 CAPSULE in 1 BOTTLE, PLASTIC (63187-854-60) 60 capsule2017-06-010000-00-00NoNoCurrent