What is NDC 84677-053?

84677-053 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 Golden State Medical Supply, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Sitagliptin phosphate, Metformin hydrochloride.

Golden State Medical Supply, Inc., NDC labeler code 84677. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sitagliptin and Metformin Hydrochloride NDC 84677-053

NDC codes

FDA NDC Directory

Product NDC (as listed)84677-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84677-0053Add 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
84677-053-18	8467700531884677005318	180 TABLET, FILM COATED in 1 BOTTLE (84677-053-18)Marketed from Jun 1, 2026
84677-053-60	8467700536084677005360	60 TABLET, FILM COATED in 1 BOTTLE (84677-053-60)Marketed from Jun 1, 2026

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): Sitagliptin and Metformin Hydrochloride
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: Golden State Medical Supply, Inc.NDC labeler code 84677
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202426
Marketing start: Apr 30, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 84677-053_58f0e7eb-dbcc-7207-e063-6294a90a40b1SPL ID 58f0e7eb-dbcc-7207-e063-6294a90a40b1SPL set ID 58f0e875-5d9b-be0b-e063-6394a90a5345RxCUI 2709488, 2709491UNII 786Z46389E, TS63EW8X6F
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

N484677005318 followed by a unit qualifier and the quantity

Package 84677-0053-18. 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 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Sitagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin and metformin hydrochloride tablets should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2)]. Sitagliptin and metformin hydrochloride tablets is a combination of sitag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 84677-053

What is NDC 84677-053?: 84677-053 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 Golden State Medical Supply, Inc.. 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?: Golden State Medical Supply, Inc., NDC labeler code 84677. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-317	10370-0317-02
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-318	10370-0318-02
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-351	10370-0351-11
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3658	60505-3658-0660505-3658-07
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3659	60505-3659-0660505-3659-07
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-052	84677-0052-1884677-0052-60
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5801	00781-5801-0500781-5801-6000781-5801-71
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5802	00781-5802-6000781-5802-7100781-5802-73
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2036	70710-2036-06
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2037	70710-2037-06

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
Product	Strength	Form · route	Labeler	Product NDC
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3658
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3659
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-052