Prescription drug · ANDA
Pioglitazone Hydrochloride NDC 84677-027
Pioglitazone hydrochloride 30 mg/1 · Tablet · Oral · GSMS, Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84677-027-05 | 84677002705 | 500 TABLET in 1 BOTTLE (84677-027-05)Marketed from Jun 20, 2026 | |
| 84677-027-30 | 84677002730 | 30 TABLET in 1 BOTTLE (84677-027-30)Marketed from Jun 20, 2026 | |
| 84677-027-90 | 84677002790 | 90 TABLET in 1 BOTTLE (84677-027-90)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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- GSMS, Incorporated
- 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 84677-027_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
N484677002705followed by a unit qualifier and the quantityPackage 84677-0027-05. 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.
Other NDCs under ANDA 210165
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-179 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-178 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-180 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | GSMS, Incorporated | 84677-026 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | GSMS, Incorporated | 84677-028 |