Home NDC 0185-0640 lisinopril
Product NDC 0185-0640
11-digit product format 001850640
Labeler code 0185
Product ID 0185-0640_a9e1ba16-fb5e-4d16-829c-bada7356fc00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisinopril
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA075994
Marketing category ANDA
Marketing start 2016-07-28
Marketing end 2022-08-31
Substance LISINOPRIL
Active strength 40 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075994-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 A075994-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 A075994-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 A075994-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 A075994-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 A075994-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 · 246 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 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-005 LISINOPRIL 30MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075994-006 LISINOPRIL 40MG TABLET / ORAL AB 2002-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075994-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075994-002 LISINOPRIL 5MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075994-003 LISINOPRIL 10MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075994-004 LISINOPRIL 20MG TABLET / ORAL AB 2002-07-01 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [EON LABS, INC.] 32 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET [EON LABS, INC.] 32 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LISINOPRIL TABLET [EON LABS, INC.] 32 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LISINOPRIL TABLET [EON LABS, INC.] 32 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL TABLET [EON LABS, INC.] 32 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [EON LABS, INC.] 32 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [EON LABS, INC.] 32 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [EON LABS, INC.] 32 LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET LISINOPRIL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [DIRECTRX] 1 LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET [DIRECTRX] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LISINOPRIL TABLET [DIRECTRX] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL TABLET [DIRECTRX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [DIRECTRX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [DIRECTRX] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [DIRECTRX] 1
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 0185-0640-01 00185064001 100 TABLET in 1 BOTTLE (0185-0640-01) 100 tablet 2016-07-28 2021-11-30 No No Current 0185-0640-10 00185064010 1000 TABLET in 1 BOTTLE (0185-0640-10) 1000 tablet 2016-07-28 2022-08-31 No No Current