Inpefa (sotagliflozin) NDC 70183-221

NDC codes

FDA NDC Directory

Product NDC (as listed)70183-221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70183-0221Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
70183-221-07	70183022107	1 BLISTER PACK in 1 CARTON (70183-221-07) / 7 TABLET in 1 BLISTER PACKMarketed from Jan 15, 2024 · Sample package
70183-221-30	70183022130	30 TABLET in 1 BOTTLE (70183-221-30)Marketed from Mar 1, 2024
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 PACKMarketed from Dec 1, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Inpefa
Generic name (nonproprietary): sotagliflozin
Active ingredients: Sotagliflozin — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lexicon Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216203
Marketing start: May 26, 2023
Listing expires: Dec 31, 2027
Other FDA classes: P-Glycoprotein Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 70183-221_2179079d-1c89-44b3-9b9c-2001d46310a1SPL ID 2179079d-1c89-44b3-9b9c-2001d46310a1SPL set ID 1a46614e-05f6-421a-b6f4-d6f8760d643aRxCUI 2638683, 2638689, 2638691, 2638693UNII 6B4ZBS263YUPC 0370183241300, 0370183221302, 0300000000001
Pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470183022107 followed by a unit qualifier and the quantity

Package 70183-0221-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 12, 2026.

Indications (excerpt from the label)

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure ( 1 ) or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216203

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216203
Product	Strength	Form · route	Labeler	Product NDC
Inpefasotagliflozin	Sotagliflozin 400 mg/1	TabletOral	Lexicon Pharmaceuticals, Inc.	70183-241