What is NDC 0378-4706?

0378-4706 is the product NDC for Saxagliptin, Saxagliptin hydrochloride dihydrate 5 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Saxagliptin hydrochloride dihydrate.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Saxagliptin?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Saxagliptin NDC 0378-4706 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4706Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4706Add 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
0378-4706-77	0037847067700378470677	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4706-77)Marketed from Aug 4, 2023
0378-4706-93	0037847069300378470693	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4706-93)Marketed from Aug 4, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): saxagliptin
Active ingredients: Saxagliptin hydrochloride dihydrate — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205980
Marketing start: Aug 4, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0378-4706_5844f950-ed79-43de-a6c4-2233878a9222SPL ID 5844f950-ed79-43de-a6c4-2233878a9222SPL set ID 6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78RxCUI 858036, 858042UNII 4N19ON48ZNUPC 0303784705933
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

N400378470677 followed by a unit qualifier and the quantity

Package 00378-4706-77. 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 Feb 28, 2025.

Indications (excerpt from the label)

Saxagliptin tablets are 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. ( 1.1 ) Limitations of use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Saxagliptin 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) ]. 1.2 Limitations of Use Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-4706

What is NDC 0378-4706?: 0378-4706 is the product NDC for Saxagliptin, Saxagliptin hydrochloride dihydrate 5 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Saxagliptin.
What is the active ingredient?: Saxagliptin hydrochloride dihydrate.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Saxagliptin?: 5 other product NDCs are listed under this name. See all Saxagliptin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Saxagliptin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Saxagliptin	Saxagliptin hydrochloride dihydrate 2.5 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4705	00378-4705-7700378-4705-93
Saxagliptin	Saxagliptin hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-825	65862-0825-0165862-0825-0565862-0825-30+1 more
Saxagliptin	Saxagliptin hydrochloride 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-826	65862-0826-0165862-0826-0565862-0826-30+1 more
Saxagliptin	Saxagliptin hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-726	68462-0726-0568462-0726-3068462-0726-90
Saxagliptin	Saxagliptin hydrochloride 5 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-727	68462-0727-0568462-0727-1468462-0727-30+1 more

Other NDCs under ANDA 205980

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

FDA NDC Directory listings under ANDA 205980
Product	Strength	Form · route	Labeler	Product NDC
Saxagliptin	Saxagliptin hydrochloride dihydrate 2.5 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4705