Home NDC 55111-439-78 Ramipril
Product NDC 55111-439
Requested package NDC 55111-439-78
11-digit product format 551110439
Labeler code 55111
Product ID 55111-439_9ca7716b-2236-623f-f9f7-19bf7b29ea85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA078191
Marketing category ANDA
Marketing start 2008-06-18
Marketing end 0000-00-00
Substance RAMIPRIL
Active strength 3 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 A078191-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 A078191-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 A078191-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 A078191-004 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 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078191-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078191-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078191-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078191-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078191-004 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.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-439-78 55111043978 10 BLISTER PACK in 1 CARTON (55111-439-78) > 10 CAPSULE in 1 BLISTER PACK (55111-439-79) 10 blister pack 2008-06-18 0000-00-00 No No Current