Prescription drug · ANDA
Atenolol and Chlorthalidone NDC 70954-390
Atenolol 50 mg/1; Chlorthalidone 25 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-390-10 | 70954039010 | 100 TABLET in 1 BOTTLE (70954-390-10)Marketed from Oct 25, 2021 |
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)
- Atenolol and Chlorthalidone
- Generic name (nonproprietary)
- atenolol and chlorthalidone
- Active ingredients
- Atenolol — 50 mg/1Chlorthalidone — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215560
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 70954-390_1dade55e-a8a5-4e38-8ad7-9caa4ceb0cd0SPL ID 1dade55e-a8a5-4e38-8ad7-9caa4ceb0cd0SPL set ID 33690cc7-fffc-4620-888d-7f6453fe58c1RxCUI 197382, 197383UNII 50VV3VW0TI, Q0MQD1073QUPC 0370954390107, 0370954391104
- 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
N470954039010followed by a unit qualifier and the quantityPackage 70954-0390-10. 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 & USAGE Atenolol and Chlorthalidone Tablets, USP are 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 th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215560
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 Chlorthalidoneatenolol and chlorthalidone tablet | Chlorthalidone 25 mg/1; Atenolol 50 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-733 |
| Atenolol And Chlorthalidoneatenolol and chlorthalidone tablet | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-734 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-391 |