Home NDC 51407-709 Ramipril
Product NDC 51407-709
11-digit product format 514070709
Labeler code 51407
Product ID 51407-709_9f641c30-6ffa-4765-8991-cc15976b111d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler GSMS, Incorporated
Application ANDA079116
Marketing category ANDA
Marketing start 2025-07-08
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 2026-12-31
Current FDA listing Yes 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 A079116-001 RAMIPRIL RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 A079116-002 RAMIPRIL RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 A079116-003 RAMIPRIL RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 A079116-004 RAMIPRIL RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20
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 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079116-001 RAMIPRIL 1.25MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-002 RAMIPRIL 2.5MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-003 RAMIPRIL 5MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079116-004 RAMIPRIL 10MG CAPSULE / ORAL AB 2008-06-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ramipril
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMIPRIL 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L35JN3I7SJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198188 Internal RxNorm lookup 198189 Internal RxNorm lookup 261962 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-709-01 Ramipril 100 in 1 BOTTLE CAPSULE 100 3
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-709-01 51407070901 100 CAPSULE in 1 BOTTLE (51407-709-01) 100 capsule 2025-07-08 No No Current