NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2264Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2264Add 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
68071-2264-3680712264036807122640330 TABLET in 1 BOTTLE (68071-2264-3)Marketed from Sep 17, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202467
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 68071-2264_1d7692c3-44e3-f52d-e063-6394a90aa73fSPL ID 1d7692c3-44e3-f52d-e063-6394a90aa73fSPL set ID af863b9e-9646-3b1e-e053-2995a90ab93aRxCUI 312440UNII JQT35NPK6CUPC 0368071226430
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

N468071226403 followed by a unit qualifier and the quantity

Package 68071-2264-03. 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, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP 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 hydrochloride is a thiazolidinedione and an agonist for peroxisome proliferator-activate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-2264

What is NDC 68071-2264?
68071-2264 is the product NDC for Pioglitazone, Pioglitazone hydrochloride 30 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, 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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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.

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

Other Pioglitazone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-418768788-4187-0168788-4187-0368788-4187-06+1 more
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralAmerican Health Packaging60687-90560687-0905-21
PioglitazonePioglitazone hydrochloride 15 mg/1TabletOralAvKARE42291-95942291-0959-3042291-0959-90
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralAvKARE42291-96042291-0960-3042291-0960-90
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralAvKARE42291-96142291-0961-3042291-0961-50
PioglitazonePioglitazone hydrochloride 15 mg/1TabletOralNorthStar RxLLC16714-64516714-0645-0116714-0645-0216714-0645-03
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralNorthStar RxLLC16714-64616714-0646-0116714-0646-0216714-0646-03
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralNorthStar RxLLC16714-64716714-0647-0116714-0647-0216714-0647-03
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralA-S Medication Solutions50090-641250090-6412-0050090-6412-01
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralA-S Medication Solutions50090-687350090-6873-0050090-6873-01

All 44 Pioglitazone NDCs

Other NDCs under ANDA 202467

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

FDA NDC Directory listings under ANDA 202467
ProductStrengthForm · routeLabelerProduct NDC
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralA-S Medication Solutions50090-6412
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4187
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralA-S Medication Solutions50090-6873
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralA-S Medication Solutions50090-6874
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralMacleods Pharmaceuticals Limited33342-055
PioglitazonePioglitazone hydrochloride 15 mg/1TabletOralMacleods Pharmaceuticals Limited33342-054
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralMacleods Pharmaceuticals Limited33342-056
PioglitazonePioglitazone hydrochloride 30 mg/1TabletOralNorthStar RxLLC16714-646
PioglitazonePioglitazone hydrochloride 15 mg/1TabletOralNorthStar RxLLC16714-645
PioglitazonePioglitazone hydrochloride 45 mg/1TabletOralNorthStar RxLLC16714-647

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