Prescription drug · ANDA

Pioglitazone Hydrochloride NDC 84677-026

Pioglitazone hydrochloride 15 mg/1 · Tablet · Oral · GSMS, Incorporated

NDC codes

FDA NDC Directory
Product NDC (as listed)84677-026Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84677-0026Add 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
84677-026-0584677002605500 TABLET in 1 BOTTLE (84677-026-05)Marketed from Jun 20, 2026
84677-026-308467700263030 TABLET in 1 BOTTLE (84677-026-30)Marketed from Jun 20, 2026
84677-026-908467700269090 TABLET in 1 BOTTLE (84677-026-90)Marketed from Jun 20, 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)
Pioglitazone Hydrochloride
Generic name (nonproprietary)
pioglitazone hydrochloride
Active ingredients
Pioglitazone hydrochloride — 15 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210165
Marketing start
Listing expires
Other FDA classes
Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers
Product ID 84677-026_0c6fcd95-9c2f-4d3d-8ec1-730e5d7f38baSPL ID 0c6fcd95-9c2f-4d3d-8ec1-730e5d7f38baSPL set ID d740d2a2-b26d-4b16-aedc-e4b4b1c94daaRxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0384677027059, 0384677026052, 0384677028056
Pharmacologic class
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

N484677002605 followed by a unit qualifier and the quantity

Package 84677-0026-05. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Monotherapy and Combination Therapy Pioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ] . Pioglitazone Tablets is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210165

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

FDA NDC Directory listings under ANDA 210165
ProductStrengthForm · routeLabelerProduct NDC
Pioglitazone HydrochloridePioglitazone hydrochloride 30 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.76385-179
Pioglitazone HydrochloridePioglitazone hydrochloride 15 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.76385-178
Pioglitazone HydrochloridePioglitazone hydrochloride 45 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.76385-180
Pioglitazone HydrochloridePioglitazone hydrochloride 30 mg/1TabletOralGSMS, Incorporated84677-027
Pioglitazone HydrochloridePioglitazone hydrochloride 45 mg/1TabletOralGSMS, Incorporated84677-028

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Pioglitazone Hydrochloride NDC 84677-026 | Med-Code