Home NDC 42291-692 Ramipril
Product NDC 42291-692
11-digit product format 422910692
Labeler code 42291
Product ID 42291-692_64027065-5929-c685-e053-2991aa0aaffc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler AvKARE, Inc.
Application ANDA078745
Marketing category ANDA
Marketing start 2017-03-23
Marketing end 0000-00-00
Substance RAMIPRIL
Active strength 5 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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42291-692-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42291-692-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42291-692-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42291-692-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42291-692-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42291-692-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42291-692-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42291-692-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42291-692-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42291-692-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42291-692-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42291-692-01 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078745-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 A078745-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 A078745-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 A078745-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078745-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078745-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078745-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078745-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
FDA-Initiated Inactive NDC Indexing# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ramipril RAMIPRIL Chartwell RX, LLC. b7e49f05-6d4f-465a-b0d7-f704466a2e52 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078745 application number: ANDA078745
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-692-01 42291069201 100 CAPSULE in 1 BOTTLE (42291-692-01) 100 capsule 2017-03-23 0000-00-00 No No Current