Prescription drug · ANDA
Pioglitazone NDC 57237-220
Pioglitazone hydrochloride 30 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-220-05 | 5723702200557237022005 | 500 TABLET in 1 BOTTLE (57237-220-05)Marketed from Feb 13, 2013 | |
| 57237-220-30 | 5723702203057237022030 | 30 TABLET in 1 BOTTLE (57237-220-30)Marketed from Feb 13, 2013 | |
| 57237-220-90 | 5723702209057237022090 | 90 TABLET in 1 BOTTLE (57237-220-90)Marketed from Jun 12, 2019 |
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
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 57237
- 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 57237-220_f3308268-8023-434e-8caf-734ca298b98eSPL ID f3308268-8023-434e-8caf-734ca298b98eSPL set ID 4483b1c6-7095-4a63-8128-ac2d91e11040RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0357237221303, 0357237220306, 0357237219300
- 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
N457237022005followed by a unit qualifier and the quantityPackage 57237-0220-05. 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 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.
About NDC 57237-220
- What is NDC 57237-220?
- 57237-220 is the product NDC for Pioglitazone, Pioglitazone hydrochloride 30 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pioglitazone.
- What is the active ingredient?
- Pioglitazone hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 57237. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pioglitazone?
- 43 other product NDCs are listed under this name. See all Pioglitazone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pioglitazone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4187 | 68788-4187-0168788-4187-0368788-4187-06+1 more |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | American Health Packaging | 60687-905 | 60687-0905-21 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | AvKARE | 42291-959 | 42291-0959-3042291-0959-90 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | AvKARE | 42291-960 | 42291-0960-3042291-0960-90 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | AvKARE | 42291-961 | 42291-0961-3042291-0961-50 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | NorthStar RxLLC | 16714-645 | 16714-0645-0116714-0645-0216714-0645-03 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | NorthStar RxLLC | 16714-646 | 16714-0646-0116714-0646-0216714-0646-03 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | NorthStar RxLLC | 16714-647 | 16714-0647-0116714-0647-0216714-0647-03 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | A-S Medication Solutions | 50090-6412 | 50090-6412-0050090-6412-01 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-6873 | 50090-6873-0050090-6873-01 |
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 Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-6393 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9664 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-4605 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1298 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2129 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | Proficient Rx LP | 82804-111 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1343 |
| Pioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1759 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4519 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5199 |
| Pioglitazone | Pioglitazone hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5210 |
| Pioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-495 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 30 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-104 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 15 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-103 |
| Pioglitazone Hydrochloride | Pioglitazone hydrochloride 45 mg/1 | TabletOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-105 |
| 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 | Pioglitazone hydrochloride 30 mg/1 | TabletOral | DIRECT RX | 72189-105 |
| 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 |
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