Lisinopril

Product NDC
64679-929
Requested package NDC
64679-929-01
11-digit product format
646790929
Labeler code
64679
Product ID
64679-929_b760b89e-02b4-8439-e053-2a95a90a9de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA078402
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
0000-00-00
Substance
LISINOPRIL
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64679-92964679-929-01DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A078402-001LISINOPRILLISINOPRIL2.5MGTABLET / ORALAB2007-04-19
A078402-002LISINOPRILLISINOPRIL5MGTABLET / ORALAB2007-04-19
A078402-003LISINOPRILLISINOPRIL10MGTABLET / ORALAB2007-04-19
A078402-004LISINOPRILLISINOPRIL20MGTABLET / ORALAB2007-04-19
A078402-005LISINOPRILLISINOPRIL30MGTABLET / ORALAB2007-04-19
A078402-006LISINOPRILLISINOPRIL40MGTABLET / ORALAB2007-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A078402-001AB
A078402-002AB
A078402-003AB
A078402-004AB
A078402-005AB
A078402-006AB

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 06:07:402026-07A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-005LISINOPRIL30MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-006LISINOPRIL40MGTABLET / ORALAB2007-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-001LISINOPRIL2.5MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-002LISINOPRIL5MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-003LISINOPRIL10MGTABLET / ORALAB2007-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-004LISINOPRIL20MGTABLET / ORALAB2007-04-1903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078402-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078402-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078402-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078402-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078402-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078402-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078402-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078402-004AB103ed91905a0d…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-929-012025-12-23These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-022025-12-23These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-032025-12-23These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-052025-12-23These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-062025-12-23These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-012023-01-30These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-022023-01-30These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-032023-01-30These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-052023-01-30These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
64679-929-062023-01-30These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS. LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-929-01EA - Each64679-929f591988a-e80d-478a-a806-24f00ffb14d212012-07-24
64679-929-05EA - Each64679-929d3af3bad-d7cc-4819-8602-c00849d8aa3f12012-07-24
64679-929-06EA - Each64679-929c9afc986-e917-4107-beb7-d95e2379df8612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIEDINACTIVE INGREDIENTQG4MW19XYXLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
POVIDONESINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [WOCKHARDT USA LLC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELISINOPRIL TABLET [WOCKHARDT USA LLC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LISINOPRIL TABLET [WOCKHARDT USA LLC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [WOCKHARDT USA LLC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-929LISINOPRIL TABLET [WOCKHARDT USA LLC.]5Legacy NDC20201227_e927801e-5de4-44f9-b543-789c093de655.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-929-0164679092901100 TABLET in 1 BOTTLE (64679-929-01) 100 tablet2007-04-190000-00-00NoNoCurrent