Prescription drug · NDA AUTHORIZED GENERIC
Bexagliflozin NDC 82381-2000
Bexagliflozin 20 mg/1 · Tablet · Oral · TheracosBio, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82381-2000-8 | 82381200008 | 30 TABLET in 1 BOTTLE (82381-2000-8)Marketed from Mar 19, 2024 | |
| 82381-2000-9 | 82381200009 | 90 TABLET in 1 BOTTLE (82381-2000-9)Marketed from Mar 19, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Bexagliflozin
- Generic name (nonproprietary)
- bexagliflozin
- Active ingredients
- Bexagliflozin — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TheracosBio, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 214373
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 82381-2000_d1529531-e021-4ae4-97bb-f5d4dd66b791SPL ID d1529531-e021-4ae4-97bb-f5d4dd66b791SPL set ID 7f0ad5d2-3509-4057-904c-d27993de7408RxCUI 2637859UNII EY00JF42FV
- 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
N482381200008followed by a unit qualifier and the quantityPackage 82381-2000-08. 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 .
Indications (excerpt from the label)
Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 214373
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brenzavvybexagliflozin | Bexagliflozin 20 mg/1 | TabletOral | TheracosBio, LLC | 82381-2174 |
| Bexagliflozin | Bexagliflozin 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-918 |