Home NDC 70183-221 INPEFA
Product NDC 70183-221
11-digit product format 701830221
Labeler code 70183
Product ID 70183-221_2179079d-1c89-44b3-9b9c-2001d46310a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sotagliflozin
Dosage form TABLET
Route ORAL
Labeler Lexicon Pharmaceuticals, Inc.
Application NDA216203
Marketing category NDA
Marketing start 2023-05-26
Substance SOTAGLIFLOZIN
Active strength 200 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 2027-12-31
Current FDA listing Yes 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 N216203-001 INPEFA SOTAGLIFLOZIN 200MG TABLET / ORAL RLD 2023-05-26 N216203-002 INPEFA SOTAGLIFLOZIN 400MG TABLET / ORAL RLD, RS 2023-05-26
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216203-001 NCE 2028-05-26 N216203-002 NCE 2028-05-26
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 2 · 50 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 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216203-001 INPEFA 200MG TABLET / ORAL RLD 2023-05-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216203-002 INPEFA 400MG TABLET / ORAL RLD, RS 2023-05-26 ea1830bbd6c7…
Observed Orange Book patent history# Patent history page 1 of 4 · 144 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 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-002 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216203-002 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-001 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-001 8476413 2028-05-29 U-3628 Drug substance, Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-001 8217156 2030-10-07 Drug substance, Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216203-002 7781577 2028-05-04 U-3628 Drug substance, Drug product 2023-06-22 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 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 INPEFA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOTAGLIFLOZIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6B4ZBS263Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2638683 Internal RxNorm lookup 2638689 Internal RxNorm lookup 2638691 Internal RxNorm lookup 2638693 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70183-221 INPEFA (SOTAGLIFLOZIN) TABLET [LEXICON PHARMACEUTICALS, INC.] 9 Current NDC, 5 package rows 20240130_1a46614e-05f6-421a-b6f4-d6f8760d643a.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INPEFA SOTAGLIFLOZIN Lexicon Pharmaceuticals, Inc. 1a46614e-05f6-421a-b6f4-d6f8760d643a 2026-08-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 216203 application number: NDA216203 ndc (product): 70183-221
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70183-221-07 70183022107 1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK 1 blister pack 2024-01-15 Yes No Current 70183-221-30 70183022130 30 TABLET in 1 BOTTLE (70183-221-30) 30 tablet 2024-03-01 No No Current 70183-221-31 70183022131 1 BLISTER PACK in 1 CARTON (70183-221-31) / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK 1 blister pack 2023-12-01 No No Current