Prescription drug · ANDA
Pioglitazone and metformin hydrochloride NDC 33342-176
Metformin hydrochloride 500 mg/1; Pioglitazone hydrochloride 15 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-176-09 | 3334201760933342017609 | 60 TABLET in 1 BOTTLE (33342-176-09)Marketed from Nov 6, 2015 | |
| 33342-176-11 | 3334201761133342017611 | 100 TABLET in 1 BOTTLE (33342-176-11)Marketed from Nov 6, 2015 | |
| 33342-176-12 | 3334201761233342017612 | 10 BLISTER PACK in 1 CARTON (33342-176-12) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 6, 2015 | |
| 33342-176-44 | 3334201764433342017644 | 1000 TABLET in 1 BOTTLE (33342-176-44)Marketed from Nov 6, 2015 | |
| 33342-176-57 | 3334201765733342017657 | 180 TABLET in 1 BOTTLE (33342-176-57)Marketed from Nov 6, 2015 |
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 and metformin hydrochloride
- Generic name (nonproprietary)
- pioglitazone and metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/1Pioglitazone hydrochloride — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204802
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
- Identifiers
- Product ID 33342-176_7d2de2ee-5ec9-4bc6-af03-2d3ac6b476a3SPL ID 7d2de2ee-5ec9-4bc6-af03-2d3ac6b476a3
- Pharmacologic class
- Biguanide; 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
N433342017609followed by a unit qualifier and the quantityPackage 33342-0176-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 33342-176
- What is NDC 33342-176?
- 33342-176 is the product NDC for Pioglitazone and metformin hydrochloride, Metformin hydrochloride 500 mg/1; Pioglitazone hydrochloride 15 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pioglitazone and metformin hydrochloride.
- What is the active ingredient?
- Metformin hydrochloride, Pioglitazone hydrochloride.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 and metformin hydrochloride?
- 3 other product NDCs are listed under this name. See all Pioglitazone and metformin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pioglitazone and metformin hydrochloride 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 and metformin hydrochloride | Metformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-177 | 33342-0177-0933342-0177-1133342-0177-12+2 more |
| Pioglitazone and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3019 | 71335-3019-01 |
| Pioglitazone and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3020 | 71335-3020-01 |
Other NDCs under ANDA 204802
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 |
|---|---|---|---|---|
| Pioglitazole and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2497 |
| Pioglitazole and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2498 |
| Pioglitazone and metformin hydrochloride | Metformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-177 |
| Pioglitazone and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3019 |
| Pioglitazone and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3020 |