Home NDC 50090-3873 Ramipril
Product NDC 50090-3873
11-digit product format 500903873
Labeler code 50090
Product ID 50090-3873_2ef2dc1c-132d-4f3a-98c4-192369e8dbda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ramipril
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA091604
Marketing category ANDA
Marketing start 2011-06-08
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 2026-12-31
Current FDA listing Yes 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 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 50090-3873-0 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 50090-3873-0 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 50090-3873-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-3873-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-3873-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-3873-0 1332a3947898…d4bfe170f9cd…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RAMIPRIL 2.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198188 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 50090-3873-0 Ramipril 100 in 1 BOTTLE CAPSULE 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3873 RAMIPRIL CAPSULE [A-S MEDICATION SOLUTIONS] 7 Current NDC, Legacy NDC, 1 package rows 20241122_4a91b706-c614-4472-92f2-4da5d7bdbf27.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 50090-3873-0 50090387300 100 CAPSULE in 1 BOTTLE (50090-3873-0) 100 capsule 2018-11-27 0000-00-00 No No Current