Home DailyMed 603a8cd1-c43d-4b72-8db3-1b0ba44e57e0 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:54:14 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.