NDC codes

FDA NDC Directory
Product NDC (as listed)60505-3659Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-3659Add 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 NDC11-digit (billing)PackageCopy
60505-3659-6605053659066050536590660 TABLET, FILM COATED in 1 BOTTLE (60505-3659-6)Marketed from May 28, 2026
60505-3659-76050536590760505365907180 TABLET, FILM COATED in 1 BOTTLE (60505-3659-7)Marketed from May 28, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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

Generic name (nonproprietary)
sitagliptin and metformin hydrochloride
Active ingredients
Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202426
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers
Product ID 60505-3659_36ef9eed-221e-a76c-c2a3-80ab897bac8aSPL ID 36ef9eed-221e-a76c-c2a3-80ab897bac8a

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

N460505365906 followed by a unit qualifier and the quantity

Package 60505-3659-06. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-3659

What is NDC 60505-3659?
60505-3659 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sitagliptin and Metformin Hydrochloride.
What is the active ingredient?
Sitagliptin phosphate, Metformin hydrochloride.
Who is the labeler?
Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sitagliptin and Metformin Hydrochloride?
18 other product NDCs are listed under this name. See all Sitagliptin 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 Sitagliptin and Metformin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sitagliptin and Metformin hydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coated, Extended releaseOralPar Health USA, LLC10370-31710370-0317-02
Sitagliptin and Metformin hydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coated, Extended releaseOralPar Health USA, LLC10370-31810370-0318-02
Sitagliptin and Metformin hydrochlorideSitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coated, Extended releaseOralPar Health USA, LLC10370-35110370-0351-11
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralApotex Corp.60505-365860505-3658-0660505-3658-07
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-05284677-0052-1884677-0052-60
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-05384677-0053-1884677-0053-60
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralSandoz Inc0781-580100781-5801-0500781-5801-6000781-5801-71
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coatedOralSandoz Inc0781-580200781-5802-6000781-5802-7100781-5802-73
Sitagliptin and Metformin HydrochlorideSitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coated, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-203670710-2036-06
Sitagliptin and Metformin HydrochlorideSitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coated, Extended releaseOralZydus Pharmaceuticals USA Inc.70710-203770710-2037-06

All 19 Sitagliptin and Metformin Hydrochloride NDCs

Other NDCs under ANDA 202426

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

FDA NDC Directory listings under ANDA 202426
ProductStrengthForm · routeLabelerProduct NDC
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralApotex Corp.60505-3658
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-052
Sitagliptin and Metformin HydrochlorideSitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-053

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