NDC codes

FDA NDC Directory
Product NDC (as listed)82381-2174Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82381-2174Add 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 NDC11-digit (billing)PackageCopy
82381-2174-18238121740130 TABLET in 1 BOTTLE (82381-2174-1)Marketed from Jul 13, 2023
82381-2174-28238121740290 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

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

N482381217401 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 214373
ProductStrengthForm · routeLabelerProduct NDC
BexagliflozinBexagliflozin 20 mg/1TabletOralGolden State Medical Supply, Inc.51407-918
BexagliflozinBexagliflozin 20 mg/1TabletOralTheracosBio, LLC82381-2000

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