Prescription drug · ANDA
Chlorthalidone NDC 68788-8294
Chlorthalidone 25 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8294-3 | 68788829403 | 30 TABLET in 1 BOTTLE (68788-8294-3)Marketed from Apr 20, 2023 | |
| 68788-8294-9 | 68788829409 | 90 TABLET in 1 BOTTLE (68788-8294-9)Marketed from Nov 29, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214129
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 68788-8294_fcd89393-6075-4b43-aa32-54f34f74f578SPL ID fcd89393-6075-4b43-aa32-54f34f74f578SPL set ID 180cc3c7-6ab7-481b-b860-b20d3599e53fRxCUI 197499UNII 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
N468788829403followed by a unit qualifier and the quantityPackage 68788-8294-03. 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 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.
About NDC 68788-8294
- What is NDC 68788-8294?
- 68788-8294 is the product NDC for Chlorthalidone, Chlorthalidone 25 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?
- 97 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 25 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-425 | 33342-0425-0733342-0425-1033342-0425-11+1 more |
| 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 | 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 214129
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 | Northwind Health Company, LLC | 51655-992 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-216 |
| Chlorthalidone | Chlorthalidone 50 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-217 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | Direct_Rx | 72189-507 |
| Chlorthalidone | Chlorthalidone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5643 |