Prescription drug · ANDA
Pioglitazone NDC 0904-7096
Pioglitazone hydrochloride 30 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7096-61 | 00904709661 | 100 BLISTER PACK in 1 CARTON (0904-7096-61) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 13, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200268
- 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 0904-7096_d6214729-9c39-4bfe-8819-aa818ef5fb69SPL ID d6214729-9c39-4bfe-8819-aa818ef5fb69SPL set ID 72b46a1e-d9ea-4a47-95ef-5eae96ef1e7fRxCUI 312440, 317573UNII JQT35NPK6C
- 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
N400904709661followed by a unit qualifier and the quantityPackage 00904-7096-61. 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 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 is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma ind…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200268
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 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-4605 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-495 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | DIRECT RX | 72189-105 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | A-S Medication Solutions | 50090-6384 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-6386 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-6393 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2129 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-103 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-104 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-105 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5199 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4519 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5210 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7511 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7514 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-514 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-512 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-513 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9664 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2609 |
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