Prescription drug · ANDA
Pioglitazone Hydrochloride NDC 62135-804
Pioglitazone hydrochloride 15 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-804-30 | 62135080430 | 30 TABLET in 1 BOTTLE (62135-804-30)Marketed from Aug 22, 2024 | |
| 62135-804-90 | 62135080490 | 90 TABLET in 1 BOTTLE (62135-804-90)Marketed from Aug 22, 2024 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076798
- 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 62135-804_42c9ddc6-1aae-a645-e063-6294a90a8b1aSPL ID 42c9ddc6-1aae-a645-e063-6294a90a8b1aSPL set ID 699e865a-952e-459e-a871-9b7cce475b71RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0362135804305, 0362135806309, 0362135805302
- 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
N462135080430followed by a unit qualifier and the quantityPackage 62135-0804-30. 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 (PPAR…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076798
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 | Chartwell RX, LLC | 62135-805 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Chartwell RX, LLC | 62135-806 |