Home NDC 55648-928 Lisinopril
Product NDC 55648-928
11-digit product format 556480928
Labeler code 55648
Product ID 55648-928_f68b2093-d117-4a59-aa38-83fbe1e48e87
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Wockhardt Limited
Application ANDA078402
Marketing category ANDA
Marketing start 2007-04-19
Marketing end 0000-00-00
Substance LISINOPRIL
Active strength 5 mg/1
NDC exclude flag E
Listing certified through 2018-12-31
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 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078402-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 A078402-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 A078402-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 A078402-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 A078402-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 A078402-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19
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 · 264 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 2026-10-15 13:18:30 2026-09 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078402-005 LISINOPRIL 30MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078402-006 LISINOPRIL 40MG TABLET / ORAL AB 2007-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078402-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2007-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078402-002 LISINOPRIL 5MG TABLET / ORAL AB 2007-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078402-003 LISINOPRIL 10MG TABLET / ORAL AB 2007-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078402-004 LISINOPRIL 20MG TABLET / ORAL AB 2007-04-19 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 7 of 7 · 264 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 LISINOPRIL ANHYDROUS ACTIVE MOIETY 7Q3P4BS2FD LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [LIBERTY PHARMACEUTICALS, INC.] 2 LISINOPRIL ACTIVE INGREDIENT E7199S1YWR LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 LISINOPRIL ACTIVE MOIETY E7199S1YWR LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 BROWN IRON OXIDE INACTIVE INGREDIENT 1N032N7MFO LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LISINOPRIL TABLET [WOCKHARDT LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-928 LISINOPRIL TABLET [WOCKHARDT LIMITED] 1 Legacy NDC, 6 package rows 20120227_a2b1db6a-3a3e-4d10-b627-3e83c9f52f59.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-928-01 55648092801 100 in 1 BOTTLE Historical 55648-928-02 55648092802 3000 in 1 BOTTLE Historical 55648-928-03 55648092803 10 in 1 BLISTER PACK Historical 55648-928-05 55648092805 500 in 1 BOTTLE Historical 55648-928-06 55648092806 1000 in 1 BOTTLE Historical