Home NDC 50090-4120-0 Trandolapril
Product NDC 50090-4120
Requested package NDC 50090-4120-0
11-digit product format 500904120
Labeler code 50090
Product ID 50090-4120_405b8a4d-2b70-4623-a3f1-cabe09349c99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trandolapril
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078438
Marketing category ANDA
Marketing start 2007-06-12
Marketing end 0000-00-00
Substance TRANDOLAPRIL
Active strength 2 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078438-001 TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 A078438-002 TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 A078438-003 TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078438-002 TRANDOLAPRIL 2MG TABLET / ORAL AB 2007-06-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078438-003 TRANDOLAPRIL 4MG TABLET / ORAL AB 2007-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078438-001 TRANDOLAPRIL 1MG TABLET / ORAL AB 2007-06-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4120-0 Trandolapril 30 in 1 BOTTLE TABLET 30 4 50090-4120-1 Trandolapril 90 in 1 BOTTLE, PLASTIC TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4120 TRANDOLAPRIL TABLET [A-S MEDICATION SOLUTIONS] 4 Legacy NDC, 2 package rows 20190501_1d778603-13cb-4110-9d45-8df3438d13ca.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 1 of 1 · 3 matching rows.
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 50090-4120-0 50090412000 30 TABLET in 1 BOTTLE (50090-4120-0) 30 tablet 2019-02-02 0000-00-00 No No Current