Home NDC 65862-038-05 Lisinopril
Product NDC 65862-038
Requested package NDC 65862-038-05
11-digit product format 658620038
Labeler code 65862
Product ID 65862-038_99502ee9-cea6-473a-91c1-e4b4ded719e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisinopril
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077622
Marketing category ANDA
Marketing start 2006-02-22
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077622-001 LISINOPRIL LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 A077622-002 LISINOPRIL LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 A077622-003 LISINOPRIL LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 A077622-004 LISINOPRIL LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 A077622-005 LISINOPRIL LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 A077622-006 LISINOPRIL LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22
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 · 258 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 2026-09-14 22:38:34 2026-08 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-005 LISINOPRIL 30MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077622-006 LISINOPRIL 40MG TABLET / ORAL AB 2006-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-001 LISINOPRIL 2.5MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-002 LISINOPRIL 5MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-003 LISINOPRIL 10MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077622-004 LISINOPRIL 20MG TABLET / ORAL AB 2006-02-22 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 258 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lisinopril
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISINOPRIL 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E7199S1YWR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197884 Internal RxNorm lookup 205326 Internal RxNorm lookup 311353 Internal RxNorm lookup 311354 Internal RxNorm lookup 314076 Internal RxNorm lookup 314077 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-038 LISINOPRIL TABLET [AUROBINDO PHARMA LIMITED] 26 Current NDC, Legacy NDC, 5 package rows 20230105_0e6364a4-6d66-4151-8197-d45e2a762895.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 65862-038-05 65862003805 500 TABLET in 1 BOTTLE (65862-038-05) 500 tablet 2006-02-22 0000-00-00 No No Current