Prescription drug · ANDA
Chlorthalidone NDC 75834-109
Chlorthalidone 25 mg/1 · Tablet · Oral · Nivagen Pharmaceuticals, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75834-109-01 | 75834010901 | 100 TABLET in 1 BOTTLE (75834-109-01)Marketed from May 28, 2018 | |
| 75834-109-10 | 75834010910 | 1000 TABLET in 1 BOTTLE (75834-109-10)Marketed from May 28, 2018 |
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 207222
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 75834-109_4581106c-4e01-7df9-e063-6294a90ac29fSPL ID 4581106c-4e01-7df9-e063-6294a90ac29fSPL set ID 36ef8d83-45f2-4873-b7cb-1be096d14d18RxCUI 197499, 197500UNII Q0MQD1073QUPC 0375834109015, 0375834110011
- 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
N475834010901followed by a unit qualifier and the quantityPackage 75834-0109-01. 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 alone or in combination with other antihypertensive drugs. 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 to unnecessary hazard. Diuretics do not prevent development of toxemia …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207222
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 50 mg/1 | TabletOral | Nivagen Pharmaceuticals, INC. | 75834-110 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2956 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2010 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9298 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-790 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2465 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-004 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-005 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0906 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Proficient Rx LP | 71205-592 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-961 |