What is NDC 71610-472?

71610-472 is the product NDC for Chlorthalidone, Chlorthalidone 25 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Chlorthalidone?

98 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Chlorthalidone NDC 71610-472 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-472Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0472Add 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
71610-472-30	7161004723071610047230	30 TABLET in 1 BOTTLE, PLASTIC (71610-472-30)Marketed from Oct 9, 2020
71610-472-45	7161004724571610047245	45 TABLET in 1 BOTTLE, PLASTIC (71610-472-45)Marketed from Oct 9, 2020
71610-472-60	7161004726071610047260	90 TABLET in 1 BOTTLE, PLASTIC (71610-472-60)Marketed from Oct 9, 2020

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): Chlorthalidone
Generic name (nonproprietary): chlorthalidone
Active ingredients: Chlorthalidone — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206904
Marketing start: May 17, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)
Identifiers: Product ID 71610-472_e74a8605-c417-45b6-a098-5046a5e3c446SPL ID e74a8605-c417-45b6-a098-5046a5e3c446SPL set ID aa16c3fe-c00b-4b49-bfe3-3b3f93bd647aRxCUI 197499UNII Q0MQD1073Q
Pharmacologic class: Thiazide-like Diuretic

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

N471610047230 followed by a unit qualifier and the quantity

Package 71610-0472-30. 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 Oct 28, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-472

What is NDC 71610-472?: 71610-472 is the product NDC for Chlorthalidone, Chlorthalidone 25 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Chlorthalidone.
What is the active ingredient?: Chlorthalidone.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Chlorthalidone?: 98 other product NDCs are listed under this name. See all Chlorthalidone 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 Chlorthalidone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Ipca Laboratories Limited	83980-061	83980-0061-0183980-0061-1083980-0061-13+2 more
Chlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Ipca Laboratories Limited	83980-062	83980-0062-0183980-0062-1083980-0062-13+1 more
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4169	68788-4169-0368788-4169-09
Chlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-426	33342-0426-0733342-0426-1033342-0426-11+1 more
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-425	33342-0425-0733342-0425-1033342-0425-11+1 more
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Safecor Health, LLC	48433-021	48433-0021-20
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4578	70518-4578-00
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4077	68788-4077-0368788-4077-09
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-004	60290-0004-0160290-0004-02
Chlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Umedica Laboratories USA Inc.	60290-005	60290-0005-0160290-0005-02

All 99 Chlorthalidone NDCs

Other NDCs under ANDA 206904

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

FDA NDC Directory listings under ANDA 206904
Product	Strength	Form · route	Labeler	Product NDC
Chlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-303
Chlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-304