Prescription drug · ANDA
Chlorthalidone NDC 57664-649
Chlorthalidone 50 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-649-18 | 57664064918 | 1000 TABLET in 1 BOTTLE (57664-649-18)Marketed from Nov 4, 2022 | |
| 57664-649-88 | 57664064988 | 100 TABLET in 1 BOTTLE (57664-649-88)Marketed from Feb 12, 2016 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089286
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 57664-649_eca591c9-75f8-2cbb-e053-2a95a90a7cf4SPL ID eca591c9-75f8-2cbb-e053-2a95a90a7cf4SPL set ID a304de67-cd2b-4933-937e-4eeecf6cda40RxCUI 197499, 197500UNII Q0MQD1073QUPC 0357664648889, 0357664649886
- 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
N457664064918followed by a unit qualifier and the quantityPackage 57664-0649-18. 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 .
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.
Other NDCs under ANDA 089286
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3074 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6900 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-648 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-021 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-029 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-358 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-359 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | American Health Packaging | 60687-317 |