Prescription drug · ANDA
Atenolol NDC 71335-0912
Atenolol 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0912-1 | 71335091201 | 30 TABLET in 1 BOTTLE (71335-0912-1)Marketed from Feb 17, 2016 | |
| 71335-0912-2 | 71335091202 | 100 TABLET in 1 BOTTLE (71335-0912-2)Marketed from Feb 17, 2016 | |
| 71335-0912-3 | 71335091203 | 60 TABLET in 1 BOTTLE (71335-0912-3)Marketed from Feb 17, 2016 | |
| 71335-0912-4 | 71335091204 | 90 TABLET in 1 BOTTLE (71335-0912-4)Marketed from Feb 17, 2016 | |
| 71335-0912-5 | 71335091205 | 20 TABLET in 1 BOTTLE (71335-0912-5)Marketed from Feb 17, 2016 | |
| 71335-0912-6 | 71335091206 | 10 TABLET in 1 BOTTLE (71335-0912-6)Marketed from Feb 17, 2016 |
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)
- Atenolol
- Generic name (nonproprietary)
- atenolol
- Active ingredients
- Atenolol — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076900
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-0912_16ec3f65-85d8-4c9a-b25c-da4af3e24463SPL ID 16ec3f65-85d8-4c9a-b25c-da4af3e24463SPL set ID 67d9ca94-2af6-4ebb-a5c3-8d360f741277RxCUI 197379, 197381UNII 50VV3VW0TI
- Pharmacologic class
- 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
N471335091201followed by a unit qualifier and the quantityPackage 71335-0912-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Hypertension Atenolol 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. 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 achieve blood pressure g…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076900
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 | Atenolol 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6779 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | American Health Packaging | 60687-605 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-952 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-022 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-023 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-024 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-144 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-024 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-022 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-023 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-029 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-0442 |