Home NDC 50458-140 INVOKANA
Product NDC 50458-140
11-digit product format 504580140
Labeler code 50458
Product ID 50458-140_30ca5702-272c-7528-e063-6294a90abbc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name canagliflozin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Pharmaceuticals, Inc.
Application NDA204042
Marketing category NDA
Marketing start 2013-03-29
Substance CANAGLIFLOZIN
Active strength 100 mg/1
Pharmacologic classes P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2019-12-13 00:20 UTC 2019-12 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204042-001 INVOKANA 100MG TABLET / ORAL RLD 2013-03-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204042-002 INVOKANA 300MG TABLET / ORAL RLD, RS 2013-03-29 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N204042-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N204042-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 36 · 1,428 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204042-001 7943788 2027-07-14 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 7943788*PED 2028-01-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 8513202*PED 2028-06-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-001 7943582*PED 2029-08-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943788 2027-07-14 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943788*PED 2028-01-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 8513202*PED 2028-06-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204042-002 7943582*PED 2029-08-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8222219 2025-04-11 U-493 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8222219 2025-04-11 U-2441 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8222219 2025-04-11 U-2632 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8222219*PED 2025-10-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943788 2027-07-14 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8513202 2027-12-03 U-2441 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8513202 2027-12-03 U-2632 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943788*PED 2028-01-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 8513202*PED 2028-06-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943582 2029-02-26 U-2441 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943582 2029-02-26 U-2632 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943582 2029-02-26 U-493 Drug substance, Drug product 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-001 7943582*PED 2029-08-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 8222219 2025-04-11 U-493 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 8222219 2025-04-11 U-2632 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 8222219 2025-04-11 U-2441 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 8222219*PED 2025-10-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 7943788 2027-07-14 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204042-002 8513202 2027-12-03 U-493 Drug substance, Drug product 2013-04-16 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 94 observed states.
Additional Listing Data#
Finished product Yes
Brand name base INVOKANA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CANAGLIFLOZIN 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0SAC974Z85 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1373463 Internal RxNorm lookup 1373469 Internal RxNorm lookup 1373471 Internal RxNorm lookup 1373473 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-140-01 INVOKANA 5 in 1 BOTTLE TABLET, FILM COATED 5 31 50458-140-10 INVOKANA 10 in 1 BLISTER PACK TABLET, FILM COATED 10 31 50458-140-10 INVOKANA 10 in 1 CARTON TABLET, FILM COATED 10 31 50458-140-30 INVOKANA 30 in 1 BOTTLE TABLET, FILM COATED 30 31 50458-140-50 INVOKANA 500 in 1 BOTTLE TABLET, FILM COATED 500 31 50458-140-90 INVOKANA 90 in 1 BOTTLE TABLET, FILM COATED 90 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded canagliflozin ACTIVE INGREDIENT 0SAC974Z85 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 canagliflozin anhydrous ACTIVE MOIETY 6S49DGR869 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8 WATER INACTIVE INGREDIENT 059QF0KO0R INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-140 INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.] 31 Current NDC, Legacy NDC, 6 package rows 20250322_b9057d3b-b104-4f09-8a61-c61ef9d4a3f3.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 · 4 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 50458-140-01 50458014001 5 TABLET, FILM COATED in 1 BOTTLE (50458-140-01) 2013-03-29 0000-00-00 Yes No Current 50458-140-10 50458014010 10 BLISTER PACK in 1 CARTON (50458-140-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2013-03-29 0000-00-00 No No Current 50458-140-30 50458014030 30 TABLET, FILM COATED in 1 BOTTLE (50458-140-30) 2013-03-29 0000-00-00 No No Current 50458-140-50 50458014050 500 TABLET, FILM COATED in 1 BOTTLE (50458-140-50) 2013-03-29 0000-00-00 No No Current 50458-140-90 50458014090 90 TABLET, FILM COATED in 1 BOTTLE (50458-140-90) 2013-03-29 0000-00-00 No No Current