Prescription drug · NDA
Brynovin (Sitagliptin hydrochloride oral) NDC 24338-017
Sitagliptin 25 mg/mL · Solution · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-017-01 | 2433800170124338001701 | 1 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLEMarketed from Apr 1, 2025 |
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)
- Brynovin
- Generic name (nonproprietary)
- sitagliptin hydrochloride oral
- Active ingredients
- Sitagliptin — 25 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 24338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219122
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 24338-017_9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04SPL ID 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04SPL set ID 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04RxCUI 2716485, 2716491UNII QFP0P1DV7ZUPC 0371225120010
- Pharmacologic class
- Dipeptidyl Peptidase 4 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
N424338001701followed by a unit qualifier and the quantityPackage 24338-0017-01. 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)
BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using BRYNOVIN. [see Warnings and Precautions ( 5.1 )] . BRYNOVIN is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: • BRYNOVIN is not recommended in patients…
Excerpt only. Read the full label for complete information.
About NDC 24338-017
- What is NDC 24338-017?
- 24338-017 is the product NDC for Brynovin (sitagliptin hydrochloride oral), Sitagliptin 25 mg/mL solution, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brynovin (Sitagliptin Hydrochloride Oral).
- What is the active ingredient?
- Sitagliptin.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 24338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brynovin?
- 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.