What is NDC 45802-351?

45802-351 is the product NDC for Alogliptin and Pioglitazone, Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 15 mg/1 tablet, film coated, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Alogliptin and Pioglitazone (Alogliptin Benzoate and Pioglitazone hydrochloride).

What is the active ingredient?

Alogliptin benzoate, Pioglitazone hydrochloride.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alogliptin and Pioglitazone?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alogliptin and Pioglitazone NDC 45802-351

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-351Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0351Add 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
45802-351-65	45802035165	30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65)Marketed from Apr 8, 2016

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): Alogliptin and Pioglitazone
Generic name (nonproprietary): alogliptin benzoate and pioglitazone hydrochloride
Active ingredients: Alogliptin benzoate — 25 mg/1Pioglitazone hydrochloride — 15 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022426
Marketing start: Apr 8, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 45802-351_11c471e0-6c64-4f13-b6ed-d2c80bc89f20SPL ID 11c471e0-6c64-4f13-b6ed-d2c80bc89f20SPL set ID 642b1e90-701e-42f2-bac6-a4918738e2c9RxCUI 1368410, 1368424, 1368431, 1368438UNII JQT35NPK6C, EEN99869SCUPC 0345802260659, 0345802402653, 0345802351654, 0345802499653
Pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor; Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Thiazolidinedione

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

N445802035165 followed by a unit qualifier and the quantity

Package 45802-0351-65. 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 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Alogliptin and pioglitazone tablets are a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Alogliptin and pioglitazone tablets are not recommended for use in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Alogliptin and pioglitazone tablets are not recommended for use in patients wit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-351

What is NDC 45802-351?: 45802-351 is the product NDC for Alogliptin and Pioglitazone, Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 15 mg/1 tablet, film coated, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alogliptin and Pioglitazone (Alogliptin Benzoate and Pioglitazone hydrochloride).
What is the active ingredient?: Alogliptin benzoate, Pioglitazone hydrochloride.
Who is the labeler?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alogliptin and Pioglitazone?: 3 other product NDCs are listed under this name. See all Alogliptin and Pioglitazone 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 Alogliptin and Pioglitazone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 12.5 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-260	45802-0260-65
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-402	45802-0402-65
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-499	45802-0499-65

Other NDCs under NDA 022426

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

FDA NDC Directory listings under NDA 022426
Product	Strength	Form · route	Labeler	Product NDC
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 12.5 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-260
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-402
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-499
Osenialogliptin and pioglitazone	Alogliptin benzoate 12.5 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-123
Osenialogliptin and pioglitazone	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 15 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-251
Osenialogliptin and pioglitazone	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-253
Osenialogliptin and pioglitazone	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-254