Prescription drug · ANDA
Atenolol and Chlorthalidone NDC 0591-5783
Atenolol 100 mg/1; Chlorthalidone 25 mg/1 · Tablet · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5783-01 | 00591578301 | 100 TABLET in 1 BOTTLE (0591-5783-01)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 — 100 mg/1Chlorthalidone — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- 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 0591-5783_ea2e1205-e570-4d89-bd7a-b5ec4022ababSPL ID ea2e1205-e570-4d89-bd7a-b5ec4022ababSPL set ID a6794dfa-adbb-491b-9d48-f89a44e866c5RxCUI 197382, 197383UNII Q0MQD1073Q, 50VV3VW0TIUPC 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
N400591578301followed by a unit qualifier and the quantityPackage 00591-5783-01. 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.
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 | Actavis Pharma, Inc. | 0591-5782 |
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-993 |