What is NDC 62135-804?

62135-804 is the product NDC for Pioglitazone Hydrochloride, Pioglitazone hydrochloride 15 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Chartwell RX, LLC, NDC labeler code 62135. 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 Hydrochloride?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pioglitazone Hydrochloride NDC 62135-804

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0804Add 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
62135-804-30	6213508043062135080430	30 TABLET in 1 BOTTLE (62135-804-30)Marketed from Aug 22, 2024
62135-804-90	6213508049062135080490	90 TABLET in 1 BOTTLE (62135-804-90)Marketed from Aug 22, 2024

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 Hydrochloride
Generic name (nonproprietary): pioglitazone hydrochloride
Active ingredients: Pioglitazone hydrochloride — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076798
Marketing start: Oct 28, 2020
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 62135-804_42c9ddc6-1aae-a645-e063-6294a90a8b1aSPL ID 42c9ddc6-1aae-a645-e063-6294a90a8b1aSPL set ID 699e865a-952e-459e-a871-9b7cce475b71RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0362135804305, 0362135806309, 0362135805302
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

N462135080430 followed by a unit qualifier and the quantity

Package 62135-0804-30. 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 Nov 4, 2025. 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 their 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 tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-804

What is NDC 62135-804?: 62135-804 is the product NDC for Pioglitazone Hydrochloride, Pioglitazone hydrochloride 15 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pioglitazone Hydrochloride.
What is the active ingredient?: Pioglitazone hydrochloride.
Who is the labeler?: Chartwell RX, LLC, NDC labeler code 62135. 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 Hydrochloride?: 17 other product NDCs are listed under this name. See all Pioglitazone 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-178	76385-0178-1076385-0178-3076385-0178-50+1 more
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-179	76385-0179-1076385-0179-3076385-0179-50+1 more
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	76385-180	76385-0180-1076385-0180-3076385-0180-50+1 more
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	GSMS, Incorporated	84677-026	84677-0026-0584677-0026-3084677-0026-90
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	GSMS, Incorporated	84677-027	84677-0027-0584677-0027-3084677-0027-90
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	GSMS, Incorporated	84677-028	84677-0028-0584677-0028-3084677-0028-90
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	REMEDYREPACK INC.	70518-4519	70518-4519-00
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-103	82009-0103-05
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-104	82009-0104-05
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-105	82009-0105-05

All 18 Pioglitazone Hydrochloride NDCs

Other NDCs under ANDA 076798

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

FDA NDC Directory listings under ANDA 076798
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	Chartwell RX, LLC	62135-805
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	Chartwell RX, LLC	62135-806