Saxagliptin and Metformin Hydrochloride NDC 43598-619

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-619Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0619Add 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	Copy
43598-619-30	43598061930	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-619-30)Marketed from Aug 9, 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): Saxagliptin and Metformin Hydrochloride
Generic name (nonproprietary): saxagliptin and metformin hydrochloride
Active ingredients: Saxagliptin — 5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Dr.Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207678
Marketing start: Aug 9, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 43598-619_532f1992-1010-5924-d950-5d396de7b503SPL ID 532f1992-1010-5924-d950-5d396de7b503SPL set ID 65884427-4dde-63bb-a23f-36a7779c0a6bRxCUI 1043563, 1043570, 1043578UNII 786Z46389E, 9GB927LAJWUPC 0343598618609, 0343598620305
Pharmacologic class: Biguanide; 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

N443598061930 followed by a unit qualifier and the quantity

Package 43598-0619-30. 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 Jul 8, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14 )]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 ) 1.1 Limitations of Use Saxagliptin and metformin hydrochlor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207678

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

FDA NDC Directory listings under ANDA 207678
Product	Strength	Form · route	Labeler	Product NDC
Saxagliptin and Metformin Hydrochloride	Saxagliptin 2.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Dr.Reddys Laboratories Inc	43598-618
Saxagliptin and Metformin Hydrochloride	Saxagliptin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Dr.Reddys Laboratories Inc	43598-620