What is NDC 68071-4964?

68071-4964 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pioglitazone NDC 68071-4964 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-4964Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-4964Add 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 NDC	11-digit (billing)	Package	Copy
68071-4964-3	6807149640368071496403	30 TABLET in 1 BOTTLE (68071-4964-3)Marketed from Jul 10, 2019

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 200268
Marketing start: Feb 13, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 68071-4964_1b2e76bd-77d9-7dcb-e063-6394a90a5c7cSPL ID 1b2e76bd-77d9-7dcb-e063-6394a90a5c7cSPL set ID 8d5ac747-991f-30e4-e053-2a95a90a4780RxCUI 312440UNII JQT35NPK6CUPC 0368071496437
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

N468071496403 followed by a unit qualifier and the quantity

Package 68071-4964-03. 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 Jun 18, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68071-4964

What is NDC 68071-4964?: 68071-4964 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
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

All 44 Pioglitazone NDCs

Other NDCs under ANDA 200268

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

FDA NDC Directory listings under ANDA 200268
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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