Home NDC 70518-1865 Lantus
Product NDC 70518-1865
11-digit product format 705181865
Labeler code 70518
Product ID 70518-1865_81dd2dec-52c3-29d9-e053-2a91aa0a3e48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name insulin glargine
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler REMEDYREPACK INC.
Application NDA021081
Marketing category NDA
Marketing start 2019-02-13
Marketing end 0000-00-00
Substance INSULIN GLARGINE
Active strength 100 [iU]/mL
Pharmacologic classes Insulin [Chemical/Ingredient],Insulin Analog [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-1865-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-1865-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-1865-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-1865-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-1865-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-1865-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-1865-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-1865-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-1865-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-1865-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-1865-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-1865-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 N021081-001 LANTUS 100 UNITS/ML INJECTABLE / INJECTION RLD, RS 2000-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 LANTUS SOLOSTAR 300 UNITS/3ML (100 UNITS/ML) INJECTABLE / INJECTION RLD, RS 2007-04-27 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021081-001 LANTUS 100 UNITS/ML INJECTABLE / INJECTION RLD, RS 2000-04-20 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 LANTUS SOLOSTAR 300 UNITS/3ML (100 UNITS/ML) INJECTABLE / INJECTION RLD, RS 2007-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021081-001 LANTUS 100 UNITS/ML INJECTABLE / INJECTION RLD, RS 2000-04-20 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021081-002 LANTUS SOLOSTAR 300 UNITS/3ML (100 UNITS/ML) INJECTABLE / INJECTION RLD, RS 2007-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021081-001 LANTUS 100 UNITS/ML INJECTABLE / INJECTION RLD, RS 2000-04-20 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021081-002 LANTUS SOLOSTAR 300 UNITS/3ML (100 UNITS/ML) INJECTABLE / INJECTION RLD, RS 2007-04-27 ea99ee380514…
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021081-001 7713930 2023-06-13 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-001 7476652 2023-07-23 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-001 7713930*PED 2023-12-13 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-001 7476652*PED 2024-01-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-001 7918833 2027-09-23 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-001 7918833*PED 2028-03-23 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 8603044 2024-03-02 Drug product 2014-01-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9233211 2024-03-02 Drug product 2016-01-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9408979 2024-03-02 Drug product 2016-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9526844 2024-03-02 Drug product 2016-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9604008 2024-03-02 Drug product 2017-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9610409 2024-03-02 Drug product 2017-04-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9775954 2024-03-02 Drug product 2017-10-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9827379 2024-03-02 U-2146 Drug product 2017-11-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 8556864 2024-03-03 Drug product 2013-11-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9011391 2024-03-26 U-1832 2015-05-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 8992486 2024-06-05 Drug product 2015-04-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9604009 2024-08-16 Drug product 2017-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9533105 2024-08-17 Drug product 2017-01-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9623189 2024-08-19 Drug product 2017-04-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9561331 2024-08-28 Drug product 2017-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 8512297 2024-09-15 Drug product 2013-08-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 8679069 2025-04-12 Drug product 2014-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021081-002 9717852 2033-04-08 Drug product 2018-07-11 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021081-001 7713930 2023-06-13 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-001 7476652 2023-07-23 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-001 7713930*PED 2023-12-13 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-001 7476652*PED 2024-01-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-001 7918833 2027-09-23 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-001 7918833*PED 2028-03-23 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 8603044 2024-03-02 Drug product 2014-01-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9233211 2024-03-02 Drug product 2016-01-13 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9408979 2024-03-02 Drug product 2016-09-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9526844 2024-03-02 Drug product 2016-12-27 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9604008 2024-03-02 Drug product 2017-03-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9610409 2024-03-02 Drug product 2017-04-04 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9775954 2024-03-02 Drug product 2017-10-03 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9827379 2024-03-02 U-2146 Drug product 2017-11-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 8556864 2024-03-03 Drug product 2013-11-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021081-002 9011391 2024-03-26 U-1832 2015-05-01 3f01610625f2…