Pioglitazone NDC 43547-428

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-428Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0428Add 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
43547-428-03	43547042803	30 TABLET in 1 BOTTLE (43547-428-03)Marketed from May 20, 2018
43547-428-09	43547042809	90 TABLET in 1 BOTTLE (43547-428-09)Marketed from May 20, 2018
43547-428-50	43547042850	500 TABLET in 1 BOTTLE (43547-428-50)Marketed from May 20, 2018

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
Generic name (nonproprietary): pioglitazone
Active ingredients: Pioglitazone — 45 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207806
Marketing start: May 20, 2018
Listing expires: Dec 31, 2026
Other FDA classes: PPAR alpha (Chemical structure)PPAR gamma (Chemical structure)Peroxisome Proliferator-activated Receptor Activity (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 43547-428_258c9ca5-41a1-44dc-8d3a-958bf6613e40SPL ID 258c9ca5-41a1-44dc-8d3a-958bf6613e40SPL set ID 1b77dbeb-61d1-4df3-872b-2f4f75a110dbRxCUI 312440, 312441, 317573UNII X4OV71U42SUPC 0343547428099, 0343547426095
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

N443547042803 followed by a unit qualifier and the quantity

Package 43547-0428-03. 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 Jan 1, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Monotherapy and Combination Therapy Pioglitazone tablets are indicated as adjuncts 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 exert their antihyperglycemic effects 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 is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207806

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

FDA NDC Directory listings under ANDA 207806
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone	Pioglitazone 15 mg/1	TabletOral	Solco Healthcare LLC	43547-426
Pioglitazone	Pioglitazone 30 mg/1	TabletOral	Solco Healthcare LLC	43547-427