Prescription drug · ANDA
Atenolol NDC 0378-0218
Atenolol 25 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0218-01 | 00378021801 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01)Marketed from Jun 17, 1999 | |
| 0378-0218-10 | 00378021810 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10)Marketed from Jun 17, 1999 |
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
- Generic name (nonproprietary)
- atenolol
- Active ingredients
- Atenolol — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073457
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0378-0218_9df3aeb2-2d70-4d49-9b45-a25e3a371cf9SPL ID 9df3aeb2-2d70-4d49-9b45-a25e3a371cf9SPL set ID a7048c81-6769-436b-8397-fbaa7489fcdfRxCUI 197379, 197380, 197381UNII 50VV3VW0TIUPC 0303780757011, 0303780218017, 0303780231016
- 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
N400378021801followed by a unit qualifier and the quantityPackage 00378-0218-01. 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 Hypertension Atenolol tablets 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. 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 p…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073457
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 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-027 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-025 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-026 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-491 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | direct rx | 72189-146 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0757 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0231 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-834 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0283 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-986 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-004 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Safecor Health, LLC | 48433-005 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Safecor Health, LLC | 48433-006 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-658 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-736 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5455 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-5511 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Proficient Rx LP | 71205-496 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-685 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-684 |
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