NDC codes

FDA NDC Directory
Product NDC (as listed)33342-176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0176Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
33342-176-09333420176093334201760960 TABLET in 1 BOTTLE (33342-176-09)Marketed from Nov 6, 2015
33342-176-113334201761133342017611100 TABLET in 1 BOTTLE (33342-176-11)Marketed from Nov 6, 2015
33342-176-12333420176123334201761210 BLISTER PACK in 1 CARTON (33342-176-12) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 6, 2015
33342-176-4433342017644333420176441000 TABLET in 1 BOTTLE (33342-176-44)Marketed from Nov 6, 2015
33342-176-573334201765733342017657180 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

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

N433342017609 followed by a unit qualifier and the quantity

Package 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pioglitazone and metformin hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pioglitazone and metformin hydrochlorideMetformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1TabletOralMacleods Pharmaceuticals Limited33342-17733342-0177-0933342-0177-1133342-0177-12+2 more
Pioglitazone and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-301971335-3019-01
Pioglitazone and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1TabletOralBryant Ranch Prepack71335-302071335-3020-01

Other NDCs under ANDA 204802

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204802
ProductStrengthForm · routeLabelerProduct NDC
Pioglitazole and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack72162-2497
Pioglitazole and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1TabletOralBryant Ranch Prepack72162-2498
Pioglitazone and metformin hydrochlorideMetformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1TabletOralMacleods Pharmaceuticals Limited33342-177
Pioglitazone and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack71335-3019
Pioglitazone and metformin hydrochloridePioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1TabletOralBryant Ranch Prepack71335-3020

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