Prescription drug · ANDA
Chlorthalidone NDC 71610-029
Chlorthalidone 25 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-029-09 | 71610002909 | 9000 TABLET in 1 BOTTLE (71610-029-09)Marketed from Jan 15, 2018 | |
| 71610-029-16 | 71610002916 | 6000 TABLET in 1 BOTTLE (71610-029-16)Marketed from Apr 16, 2019 | |
| 71610-029-30 | 71610002930 | 30 TABLET in 1 BOTTLE (71610-029-30)Marketed from May 13, 2019 | |
| 71610-029-45 | 71610002945 | 45 TABLET in 1 BOTTLE (71610-029-45)Marketed from May 13, 2019 | |
| 71610-029-60 | 71610002960 | 90 TABLET in 1 BOTTLE (71610-029-60)Marketed from May 13, 2019 | |
| 71610-029-80 | 71610002980 | 180 TABLET in 1 BOTTLE (71610-029-80)Marketed from Jun 9, 2021 |
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
- 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 71610-029_c6545c41-a482-4936-be1b-5ad77ee1f1b4SPL ID c6545c41-a482-4936-be1b-5ad77ee1f1b4SPL set ID dea660bd-d4cc-4c5b-9c6d-674a6dc1c9c2UNII 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
N471610002909followed by a unit qualifier and the quantityPackage 71610-0029-09. 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 50 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-649 |
| 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 | 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 |