What is NDC 13668-280?

13668-280 is the product NDC for Pioglitazone HCL and Metformin HCL, Metformin hydrochloride 500 mg/1; Pioglitazone hydrochloride 15 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Metformin hydrochloride, Pioglitazone hydrochloride.

Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pioglitazone HCL and Metformin HCL?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pioglitazone HCL and Metformin HCL NDC 13668-280

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0280Add 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
13668-280-05	1366802800513668028005	500 TABLET in 1 BOTTLE (13668-280-05)Marketed from Sep 1, 2025
13668-280-10	1366802801013668028010	1000 TABLET in 1 BOTTLE (13668-280-10)Marketed from Sep 1, 2025
13668-280-33	1366802803313668028033	180 TABLET in 1 BOTTLE (13668-280-33)Marketed from Sep 1, 2025
13668-280-60	1366802806013668028060	60 TABLET in 1 BOTTLE (13668-280-60)Marketed from Sep 1, 2025
13668-280-74	1366802807413668028074	100 TABLET in 1 CARTON (13668-280-74)Marketed from Sep 1, 2025

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): Pioglitazone HCL and Metformin HCL
Generic name (nonproprietary): pioglitazone hcl and metformin hcl
Active ingredients: Metformin hydrochloride — 500 mg/1Pioglitazone hydrochloride — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202001
Marketing start: Sep 1, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 13668-280_05c4925c-a14b-4229-81b0-abb0f5f3814cSPL ID 05c4925c-a14b-4229-81b0-abb0f5f3814cSPL set ID 237d8fa2-633c-4c29-84d3-f1b413610dc3RxCUI 861783, 861822UNII 786Z46389E, JQT35NPK6CUPC 0313668280609, 0313668281606
Pharmacologic class: Biguanide; 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

N413668028005 followed by a unit qualifier and the quantity

Package 13668-0280-05. 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 Sep 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Pioglitazone and metformin hydrochloride tablets, are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, 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: Not recommended for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 ) Pioglitazone 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 Pioglitazone and metformin hydrochloride tablets are not recommended to treat type 1 diab…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-280

What is NDC 13668-280?: 13668-280 is the product NDC for Pioglitazone HCL and Metformin HCL, Metformin hydrochloride 500 mg/1; Pioglitazone hydrochloride 15 mg/1 tablet, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pioglitazone HCL and Metformin HCL.
What is the active ingredient?: Metformin hydrochloride, Pioglitazone hydrochloride.
Who is the labeler?: Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pioglitazone HCL and Metformin HCL?: 1 other product NDC are listed under this name. See all Pioglitazone HCL and Metformin HCL 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 Pioglitazone HCL and Metformin HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pioglitazone HCL and Metformin HCL	Metformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-281	13668-0281-0513668-0281-3313668-0281-49+2 more

Other NDCs under ANDA 202001

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

FDA NDC Directory listings under ANDA 202001
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone HCL and Metformin HCL	Metformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1	TabletOral	Torrent Pharmaceuticals Limited	13668-281