Prescription drug · ANDA
Pioglitazone NDC 33342-055
Pioglitazone hydrochloride 30 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-055-07 | 33342005507 | 30 TABLET in 1 BOTTLE (33342-055-07)Marketed from Feb 14, 2013 | |
| 33342-055-10 | 33342005510 | 90 TABLET in 1 BOTTLE (33342-055-10)Marketed from Feb 14, 2013 | |
| 33342-055-12 | 33342005512 | 100 TABLET in 1 BOX, UNIT-DOSE (33342-055-12)Marketed from Feb 14, 2013 | |
| 33342-055-15 | 33342005515 | 500 TABLET in 1 BOTTLE (33342-055-15)Marketed from Feb 14, 2013 |
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 hydrochloride — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202467
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)PPAR gamma (Chemical structure)Peroxisome Proliferator-activated Receptor Activity (Mechanism)Thiazolidinediones (Chemical structure)
- Identifiers
- Product ID 33342-055_7d118937-d5b2-402f-8e24-f70a48c1d432SPL ID 7d118937-d5b2-402f-8e24-f70a48c1d432SPL set ID 482cef76-0623-4b4f-a0ea-f008c97b2281RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0333342056153, 0333342055101, 0333342056078, 0333342056108, 0333342054104, 0333342055071
- 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
N433342005507followed by a unit qualifier and the quantityPackage 33342-0055-07. 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, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP 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 hydrochloride is a thiazolidinedione and an agonist for peroxisome proliferator-activate…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202467
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 | NorthStar RxLLC | 16714-646 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | NorthStar RxLLC | 16714-645 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4187 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-054 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-056 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | A-S Medication Solutions | 50090-6412 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2264 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | NorthStar RxLLC | 16714-647 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-6873 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-6874 |