What is NDC 45802-211?

45802-211 is the product NDC for alogliptin and metformin hydrochloride, Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 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 is the active ingredient?

Alogliptin benzoate, Metformin 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 metformin hydrochloride?

2 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 metformin hydrochloride NDC 45802-211

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0211Add 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
45802-211-72	45802021172	60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)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 metformin hydrochloride
Generic name (nonproprietary): alogliptin and metformin hydrochloride
Active ingredients: Alogliptin benzoate — 12.5 mg/1Metformin hydrochloride — 1000 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 203414
Marketing start: Apr 8, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 45802-211_eb8e70d9-7ea0-4154-99b6-07e7ba15fe14SPL ID eb8e70d9-7ea0-4154-99b6-07e7ba15fe14SPL set ID 14d98490-4f8f-4d2f-a4e9-7a3d7a0199baRxCUI 1368385, 1368392UNII EEN99869SC, 786Z46389EUPC 0345802169723, 0345802211729
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

N445802021172 followed by a unit qualifier and the quantity

Package 45802-0211-72. 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 Aug 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Alogliptin and metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin and metformin HCl tablets are a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) 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: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Alogliptin and metformin HCl tablets should not recommended for use in patients with type 1 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-211

What is NDC 45802-211?: 45802-211 is the product NDC for alogliptin and metformin hydrochloride, Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 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 metformin hydrochloride.
What is the active ingredient?: Alogliptin benzoate, Metformin 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 metformin hydrochloride?: 2 other product NDCs are listed under this name. See all alogliptin and metformin hydrochloride 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 metformin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
alogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-169	45802-0169-72
alogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5993	50090-5993-00

Other NDCs under NDA 203414

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

FDA NDC Directory listings under NDA 203414
Product	Strength	Form · route	Labeler	Product NDC
alogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-169
alogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5993
Kazanoalogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-335
Kazanoalogliptin and metformin hydrochloride	Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-337