Home DailyMed c1339946-8a54-478e-ac6f-8013b2dc92e6 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 2013-05-02
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:08:11 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 · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204042-001 INVOKANA CANAGLIFLOZIN 100MG TABLET / ORAL AB RLD 2013-03-29 N204042-002 INVOKANA CANAGLIFLOZIN 300MG TABLET / ORAL AB RLD, RS 2013-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204042-001 7943788 2027-07-14 Drug substance, Drug product 2013-04-16 N204042-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 N204042-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 N204042-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 N204042-001 7943788*PED 2028-01-14 Pediatric extension N204042-001 8513202*PED 2028-06-03 Pediatric extension N204042-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 N204042-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 N204042-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 N204042-001 7943582*PED 2029-08-26 Pediatric extension N204042-002 7943788 2027-07-14 Drug substance, Drug product N204042-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 N204042-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 N204042-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 N204042-002 7943788*PED 2028-01-14 Pediatric extension N204042-002 8513202*PED 2028-06-03 Pediatric extension N204042-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 N204042-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 N204042-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 N204042-002 7943582*PED 2029-08-26 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 3 · 88 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 N204042-001 INVOKANA 100MG TABLET / ORAL AB RLD 2013-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 INVOKANA 300MG TABLET / ORAL AB RLD, RS 2013-03-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204042-001 INVOKANA 100MG TABLET / ORAL AB RLD 2013-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 INVOKANA 300MG TABLET / ORAL AB RLD, RS 2013-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204042-001 INVOKANA 100MG TABLET / ORAL AB RLD 2013-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204042-002 INVOKANA 300MG TABLET / ORAL AB RLD, RS 2013-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 38 · 1,488 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204042-001 7943788 2027-07-14 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 7943788*PED 2028-01-14 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 8513202*PED 2028-06-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-001 7943582*PED 2029-08-26 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943788 2027-07-14 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943788*PED 2028-01-14 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 8513202*PED 2028-06-03 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204042-002 7943582*PED 2029-08-26 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N204042-001 7943788 2027-07-14 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-001 7943582*PED 2029-08-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943788 2027-07-14 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943788*PED 2028-01-14 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 8513202*PED 2028-06-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204042-002 7943582*PED 2029-08-26 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 106 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.