Home NDC 70518-4604 Ramipril
Product NDC 70518-4604
11-digit product format 705184604
Labeler code 70518
Product ID 70518-4604_5bc1a632-9645-f056-e063-6294a90aba60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA091604
Marketing category ANDA
Marketing start 2026-04-22
Substance RAMIPRIL
Active strength 2.5 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Ramipril
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMIPRIL 2.5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4604-0 Ramipril 50 in 1 BOX CAPSULE 50 1 70518-4604-1 Ramipril 1 in 1 POUCH CAPSULE 1 1
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 Sample Exclude flag Status 70518-4604-0 70518460400 50 POUCH in 1 BOX (70518-4604-0) / 1 CAPSULE in 1 POUCH (70518-4604-1) 50 pouch 2026-04-22 No No Current 70518-4604-1 70518460401 1 in 1 POUCH Historical