Home NDC 42806-053 Trandolapril
Product NDC 42806-053
11-digit product format 428060053
Labeler code 42806
Product ID 42806-053_71e96bed-1a18-49d6-e053-2995a90a3014
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trandolapril Tablets
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA078508
Marketing category ANDA
Marketing start 2015-03-31
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078508-001 TRANDOLAPRIL TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 A078508-002 TRANDOLAPRIL TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 A078508-003 TRANDOLAPRIL TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18
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 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078508-002 TRANDOLAPRIL 4MG TABLET / ORAL AB 2008-06-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078508-003 TRANDOLAPRIL 1MG TABLET / ORAL AB 2008-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078508-001 TRANDOLAPRIL 2MG TABLET / ORAL AB 2008-06-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trandolapril
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRANDOLAPRIL 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1T0N3G9CRC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199351 Internal RxNorm lookup 199352 Internal RxNorm lookup 199353 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 42806-053-01 Trandolapril 100 in 1 BOTTLE TABLET 100 8 42806-053-10 Trandolapril 1000 in 1 BOTTLE TABLET 1000 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRANDOLAPRIL ACTIVE INGREDIENT 1T0N3G9CRC TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 TRANDOLAPRILAT ACTIVE MOIETY RR6866VL0O TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-053 TRANDOLAPRIL (TRANDOLAPRIL TABLETS) TABLET [EPIC PHARMA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20180726_10f25119-9970-46fe-bf36-6fec6064895b.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 · 1 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 42806-053-01 42806005301 100 TABLET in 1 BOTTLE (42806-053-01) 100 tablet 2015-03-31 0000-00-00 No No Current 42806-053-10 42806005310 1000 TABLET in 1 BOTTLE (42806-053-10) 1000 tablet 2015-03-31 0000-00-00 No No Current