Home NDC 45865-443 Ramipril
Product NDC 45865-443
11-digit product format 458650443
Labeler code 45865
Product ID 45865-443_71c7a685-c653-d801-e053-2a95a90aec5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler Medsource Pharmaceuticals
Application ANDA091604
Marketing category ANDA
Marketing start 2011-06-08
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-443-49 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-443-60 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-443-49 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-443-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-443-49 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-443-60 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-443-49 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-443-60 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-443-49 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-443-60 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-443-49 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-443-60 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-443-60 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-443-49 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-443-60 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-443-49 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-443-60 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-443-49 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091604-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 A091604-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 A091604-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 A091604-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08
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 · 172 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 2026-09-14 22:38:34 2026-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091604-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2011-06-08 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45865-443-49 Ramipril 100 in 1 BOTTLE CAPSULE 100 1 45865-443-60 Ramipril 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-443 RAMIPRIL CAPSULE [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 2 package rows 20180725_71c7a685-c652-d801-e053-2a95a90aec5f.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 2 of 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ramipril RAMIPRIL Proficient Rx LP d3513b8b-2d8a-456d-b942-a25ec1965b04 2019-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091604 application number: ANDA091604
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45865-443-49 45865044349 100 CAPSULE in 1 BOTTLE (45865-443-49) 100 capsule 2018-01-01 0000-00-00 No No Current 45865-443-60 45865044360 60 CAPSULE in 1 BOTTLE (45865-443-60) 60 capsule 2018-01-01 0000-00-00 No No Current