Prescription drug · ANDA
Chlorthalidone NDC 68382-971
Chlorthalidone 50 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-971-01 | 68382097101 | 100 TABLET in 1 BOTTLE (68382-971-01)Marketed from May 15, 2019 | |
| 68382-971-10 | 68382097110 | 1000 TABLET in 1 BOTTLE (68382-971-10)Marketed from May 15, 2019 |
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 207813
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 68382-971_1db5deb3-2699-4c73-a11e-1e4aa12e97fbSPL ID 1db5deb3-2699-4c73-a11e-1e4aa12e97fbSPL set ID ef8023a3-b2be-436e-9085-576781950665RxCUI 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
N468382097101followed by a unit qualifier and the quantityPackage 68382-0971-01. 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 tablets, USP 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 tablets, USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone tablets, USP 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 inap…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207813
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 | Northstar Rx LLC. | 16714-128 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Northstar Rx LLC. | 16714-129 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1369 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1370 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-970 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6958 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6957 |