FDA.reportPublic FDA data

INPEFA

Product NDC
70183-221
11-digit product format
701830221
Labeler code
70183
Product ID
70183-221_cd790640-aade-49e0-a549-6eac00d3efc2
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216203-001INPEFASOTAGLIFLOZIN200MGTABLET / ORALRLD2023-05-26
N216203-002INPEFASOTAGLIFLOZIN400MGTABLET / ORALRLD, RS2023-05-26

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216203-00177815772028-05-04U-3628Drug substance, Drug product2023-06-22
N216203-00184764132028-05-29U-3628Drug substance, Drug product2023-06-22
N216203-00182171562030-10-07Drug substance, Drug product2023-06-22
N216203-00277815772028-05-04U-3628Drug substance, Drug product2023-06-22
N216203-00284764132028-05-29U-3628Drug substance, Drug product2023-06-22
N216203-00282171562030-10-07Drug substance, Drug product2023-06-22

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216203-001NCE2028-05-26
N216203-002NCE2028-05-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N216203-001INPEFA200MGTABLET / ORALRLD2023-05-26a50c72e98297…
2026-08-01 22:54:322026-06N216203-002INPEFA400MGTABLET / ORALRLD, RS2023-05-26a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N216203-00177815772028-05-04U-3628Drug substance, Drug product2023-06-22a50c72e98297…
2026-08-01 22:54:322026-06N216203-00184764132028-05-29U-3628Drug substance, Drug product2023-06-22a50c72e98297…
2026-08-01 22:54:322026-06N216203-00182171562030-10-07Drug substance, Drug product2023-06-22a50c72e98297…
2026-08-01 22:54:322026-06N216203-00277815772028-05-04U-3628Drug substance, Drug product2023-06-22a50c72e98297…
2026-08-01 22:54:322026-06N216203-00284764132028-05-29U-3628Drug substance, Drug product2023-06-22a50c72e98297…
2026-08-01 22:54:322026-06N216203-00282171562030-10-07Drug substance, Drug product2023-06-22a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N216203-001NCE2028-05-26a50c72e98297…
2026-08-01 22:54:322026-06N216203-002NCE2028-05-26a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INPEFASOTAGLIFLOZINLexicon Pharmaceuticals, Inc.1a46614e-05f6-421a-b6f4-d6f8760d643a2026-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 216203
application number: NDA216203
ndc (product): 70183-221

Additional Listing Data#

Finished product
Yes
Brand name base
INPEFA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOTAGLIFLOZIN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6B4ZBS263YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2638683Internal RxNorm lookup
2638689Internal RxNorm lookup
2638691Internal RxNorm lookup
2638693Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a46614e-05f6-421a-b6f4-d6f8760d643aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c756bac4-3307-406f-929a-2842e7f1e9e6Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70183-221-07INPEFA7 in 1 BLISTER PACKTABLET710
70183-221-07INPEFA1 in 1 CARTONTABLET110
70183-221-30INPEFA30 in 1 BOTTLETABLET3010
70183-221-31INPEFA1 in 1 CARTONTABLET110
70183-221-31INPEFA3 in 1 BLISTER PACKTABLET310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70183-221-30EA - Each70183-221f4c2afbb-5299-49fe-a79b-81e60172bab112024-04-05
70183-221-31EA - Each70183-221afcfc458-f581-445c-8bca-f68650a7cf1e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70183-221INPEFA (SOTAGLIFLOZIN) TABLET [LEXICON PHARMACEUTICALS, INC.]9Current NDC, 5 package rows20240130_1a46614e-05f6-421a-b6f4-d6f8760d643a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2638689inpefa 200 MG Oral TabletPSN1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638693inpefa 400 MG Oral TabletPSN1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638683sotagliflozin 200 MG Oral TabletPSN1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638691sotagliflozin 400 MG Oral TabletPSN1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638689sotagliflozin 200 MG Oral Tablet [Inpefa]SBD1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638693sotagliflozin 400 MG Oral Tablet [Inpefa]SBD1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638683sotagliflozin 200 MG Oral TabletSCD1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638691sotagliflozin 400 MG Oral TabletSCD1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638689Inpefa 200 MG Oral TabletSY1a46614e-05f6-421a-b6f4-d6f8760d643a10
2638693Inpefa 400 MG Oral TabletSY1a46614e-05f6-421a-b6f4-d6f8760d643a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70183-221-07701830221071 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACK1 blister pack2024-01-15YesNoCurrent
70183-221-307018302213030 TABLET in 1 BOTTLE (70183-221-30) 30 tablet2024-03-01NoNoCurrent
70183-221-31701830221311 BLISTER PACK in 1 CARTON (70183-221-31) / 3 BLISTER PACK in 1 BLISTER PACK / 10 TABLET in 1 BLISTER PACK1 blister pack2023-12-01NoNoCurrent