Prescription drug · ANDA
Atenolol And Chlorthalidone NDC 10135-733
atenolol and chlorthalidone tablet · Chlorthalidone 25 mg/1; Atenolol 50 mg/1 · Tablet · Oral · MARLEX PHARMACEUTICALS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-733-01 | 10135073301 | 100 TABLET in 1 BOTTLE (10135-733-01)Marketed from Mar 1, 2022 |
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 tablet
- Active ingredients
- Chlorthalidone — 25 mg/1Atenolol — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MARLEX 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 10135-733_3f64b114-c891-e5a3-e063-6394a90abd98SPL ID 3f64b114-c891-e5a3-e063-6394a90abd98SPL set ID db22ff31-52f6-9024-e053-2995a90af8b3RxCUI 197382, 197383UNII 50VV3VW0TI, Q0MQD1073Q
- 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
N410135073301followed by a unit qualifier and the quantityPackage 10135-0733-01. 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 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 …
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 | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | MARLEX PHARMACEUTICALS, INC | 10135-734 |
| Atenolol and Chlorthalidone | Atenolol 50 mg/1; Chlorthalidone 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-390 |
| Atenolol and Chlorthalidone | Atenolol 100 mg/1; Chlorthalidone 25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-391 |