Prescription drug · NDA
Brenzavvy (Bexagliflozin) NDC 82381-2174
Bexagliflozin 20 mg/1 · Tablet · Oral · TheracosBio, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82381-2174-1 | 82381217401 | 30 TABLET in 1 BOTTLE (82381-2174-1)Marketed from Jul 13, 2023 | |
| 82381-2174-2 | 82381217402 | 90 TABLET in 1 BOTTLE (82381-2174-2)Marketed from Jul 13, 2023 |
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)
- Brenzavvy
- Generic name (nonproprietary)
- bexagliflozin
- Active ingredients
- Bexagliflozin — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TheracosBio, LLCNDC labeler code 82381
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214373
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 82381-2174_e4847454-8b05-4a77-9ed8-0d1d273738feSPL ID e4847454-8b05-4a77-9ed8-0d1d273738feSPL set ID 3cdf28fc-4194-4ad6-aa03-c9eaa68da83eRxCUI 2637859, 2637865UNII 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
N482381217401followed by a unit qualifier and the quantityPackage 82381-2174-01. 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)
BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . BRENZAVVY 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.
About NDC 82381-2174
- What is NDC 82381-2174?
- 82381-2174 is the product NDC for Brenzavvy (bexagliflozin), Bexagliflozin 20 mg/1 tablet, listed with the FDA by TheracosBio, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brenzavvy (Bexagliflozin).
- What is the active ingredient?
- Bexagliflozin.
- Who is the labeler?
- TheracosBio, LLC, NDC labeler code 82381. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brenzavvy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Bexagliflozin | Bexagliflozin 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-918 |
| Bexagliflozin | Bexagliflozin 20 mg/1 | TabletOral | TheracosBio, LLC | 82381-2000 |