Chlorthalidone Chlorthalidone NDC 46708-676

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-676Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0676Add 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
46708-676-31	46708067631	100 TABLET in 1 BOTTLE (46708-676-31)Marketed from Aug 29, 2022
46708-676-90	46708067690	90 TABLET in 1 BOTTLE (46708-676-90)Marketed from Aug 29, 2022
46708-676-91	46708067691	1000 TABLET in 1 BOTTLE (46708-676-91)Marketed from Aug 29, 2022

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 ChlorthalidoneSuffix: CHLORTHALIDONE
Generic name (nonproprietary): chlorthalidone
Active ingredients: Chlorthalidone — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216262
Marketing start: Aug 29, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis (Physiologic effect)
Identifiers: Product ID 46708-676_1b98d1a1-9d3d-41d2-a5e9-744b851d30d4SPL ID 1b98d1a1-9d3d-41d2-a5e9-744b851d30d4SPL set ID 1b98d1a1-9d3d-41d2-a5e9-744b851d30d4RxCUI 197499, 197500UNII 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

N446708067631 followed by a unit qualifier and the quantity

Package 46708-0676-31. 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 Sep 6, 2022.

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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216262

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

FDA NDC Directory listings under ANDA 216262
Product	Strength	Form · route	Labeler	Product NDC
Chlorthalidone Chlorthalidonechlorthalidone	Chlorthalidone 25 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-676
Chlorthalidone Chlorthalidonechlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-677
Chlorthalidone Chlorthalidonechlorthalidone	Chlorthalidone 50 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-677

Chlorthalidone Chlorthalidone (chlorthalidone) NDC 46708-676