Prescription drug · ANDA
Chlorthalidone NDC 65162-247
Chlorthalidone 25 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-247-03 | 6516202470365162024703 | 30 TABLET in 1 BOTTLE (65162-247-03)Marketed from Jul 1, 2019 | |
| 65162-247-09 | 6516202470965162024709 | 90 TABLET in 1 BOTTLE (65162-247-09)Marketed from Jul 1, 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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207204
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 65162-247_14c59688-433d-42f4-8dbe-035e6735a396SPL ID 14c59688-433d-42f4-8dbe-035e6735a396SPL set ID c4c1bfe5-b5c8-43c0-9428-62337095b2bdRxCUI 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
N465162024703followed by a unit qualifier and the quantityPackage 65162-0247-03. 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 tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy. Chlorthalidone tablets have 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 mo…
Excerpt only. Read the full label for complete information.
About NDC 65162-247
- What is NDC 65162-247?
- 65162-247 is the product NDC for Chlorthalidone, Chlorthalidone 25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorthalidone.
- What is the active ingredient?
- Chlorthalidone.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlorthalidone?
- 98 other product NDCs are listed under this name. See all Chlorthalidone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlorthalidone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-061 | 83980-0061-0183980-0061-1083980-0061-13+2 more |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-062 | 83980-0062-0183980-0062-1083980-0062-13+1 more |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4169 | 68788-4169-0368788-4169-09 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-426 | 33342-0426-0733342-0426-1033342-0426-11+1 more |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-425 | 33342-0425-0733342-0425-1033342-0425-11+1 more |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-021 | 48433-0021-20 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4578 | 70518-4578-00 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4077 | 68788-4077-0368788-4077-09 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-004 | 60290-0004-0160290-0004-02 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-005 | 60290-0005-0160290-0005-02 |
Other NDCs under ANDA 207204
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 | Amneal Pharmaceuticals LLC | 65162-250 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Coupler LLC | 67046-1495 |