FDA.reportPublic FDA data

Lisinopril

Product NDC
59115-145
11-digit product format
591150145
Labeler code
59115
Product ID
59115-145_ecedf718-c763-4bfb-8222-1b9c911587b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA076063
Marketing category
ANDA
Marketing start
2013-08-22
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076063-001LISINOPRILLISINOPRIL2.5MGTABLET / ORAL2002-07-01
A076063-002LISINOPRILLISINOPRIL5MGTABLET / ORAL2002-07-01
A076063-003LISINOPRILLISINOPRIL10MGTABLET / ORAL2002-07-01
A076063-004LISINOPRILLISINOPRIL20MGTABLET / ORAL2002-07-01
A076063-005LISINOPRILLISINOPRIL40MGTABLET / ORAL2002-07-01
A076063-006LISINOPRILLISINOPRIL30MGTABLET / ORAL2003-06-27

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-005LISINOPRIL40MGTABLET / ORAL2002-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076063-006LISINOPRIL30MGTABLET / ORAL2003-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-001LISINOPRIL2.5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-002LISINOPRIL5MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-003LISINOPRIL10MGTABLET / ORAL2002-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076063-004LISINOPRIL20MGTABLET / ORAL2002-07-0103ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076063-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076063-006AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076063-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076063-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076063-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076063-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076063-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076063-006AB1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [HIKMA PHARMACEUTICAL]2