Prescription drug · ANDA
Pioglitazone NDC 68071-5245
Pioglitazone hydrochloride 15 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5245-3 | 68071524503 | 30 TABLET in 1 BOTTLE (68071-5245-3)Marketed from Apr 29, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077210
- 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 68071-5245_1d78c52a-6d53-ff93-e063-6294a90a4864SPL ID 1d78c52a-6d53-ff93-e063-6294a90a4864SPL set ID a4751cb4-0700-dd22-e053-2995a90adfdbRxCUI 317573UNII JQT35NPK6CUPC 0368071524536
- 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
N468071524503followed by a unit qualifier and the quantityPackage 68071-5245-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Monotherapy and Combination Therapy Pioglitazone tablets are 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 exert their 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 are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077210
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 | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1333 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | AvKARE | 42291-961 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | AvKARE | 42291-959 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | AvKARE | 42291-960 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | American Health Packaging | 60687-905 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7271 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7272 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2373 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7273 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | American Health Packaging | 60687-391 |