Prescription drug · ANDA
Atenolol and Chlorthalidone NDC 0591-5782
Atenolol 50 mg/1; Chlorthalidone 25 mg/1 · Tablet · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5782-01 | 0059157820100591578201 | 100 TABLET in 1 BOTTLE (0591-5782-01)Marketed from Aug 1, 1992 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Atenolol and Chlorthalidone
- Generic name (nonproprietary)
- atenolol and chlorthalidone
- Active ingredients
- Atenolol — 50 mg/1Chlorthalidone — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073665
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 0591-5782_ea2e1205-e570-4d89-bd7a-b5ec4022ababSPL ID ea2e1205-e570-4d89-bd7a-b5ec4022ababSPL set ID a6794dfa-adbb-491b-9d48-f89a44e866c5RxCUI 197382, 197383UNII 50VV3VW0TI, Q0MQD1073QUPC 0305915782011
- Pharmacologic class
- Thiazide-like Diuretic; beta-Adrenergic Blocker
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
N400591578201followed by a unit qualifier and the quantityPackage 00591-5782-01. 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 Atenolol and chlorthalidone is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol and chlorthalidone. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to…
Excerpt only. Read the full label for complete information.
About NDC 0591-5782
- What is NDC 0591-5782?
- 0591-5782 is the product NDC for Atenolol and Chlorthalidone, Atenolol 50 mg/1; Chlorthalidone 25 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atenolol and Chlorthalidone.
- What is the active ingredient?
- Atenolol, Chlorthalidone.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atenolol and Chlorthalidone?
- 15 other product NDCs are listed under this name. See all Atenolol and Chlorthalidone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atenolol and 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) |
|---|---|---|---|---|---|
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4156 | 68788-4156-01 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4111 | 70518-4111-00 |
| Atenolol And Chlorthalidoneatenolol and chlorthalidone tablet | Chlorthalidone 25 mg/1; Atenolol 50 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-733 | 10135-0733-01 |
| Atenolol And Chlorthalidoneatenolol and chlorthalidone tablet | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-734 | 10135-0734-01 |
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-390 | 70954-0390-10 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-391 | 70954-0391-10 |
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-400 | 29300-0400-0129300-0400-05 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-401 | 29300-0401-0129300-0401-05 |
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | Northstar Rx LLC. | 16714-936 | 16714-0936-01 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | Northstar Rx LLC. | 16714-937 | 16714-0937-01 |
Other NDCs under ANDA 073665
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 |
|---|---|---|---|---|
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-993 |