Prescription drug · ANDA
Atenolol NDC 0378-0231
Atenolol 50 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0231-01 | 0037802310100378023101 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0231-01)Marketed from Jan 24, 1992 | |
| 0378-0231-10 | 0037802311000378023110 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0231-10)Marketed from Jan 24, 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
- Generic name (nonproprietary)
- atenolol
- Active ingredients
- Atenolol — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- 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 0378-0231_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
N400378023101followed by a unit qualifier and the quantityPackage 00378-0231-01. 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.
About NDC 0378-0231
- What is NDC 0378-0231?
- 0378-0231 is the product NDC for Atenolol, Atenolol 50 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atenolol.
- What is the active ingredient?
- Atenolol.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atenolol?
- 124 other product NDCs are listed under this name. See all Atenolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atenolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atenolol | Atenolol 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-925 | 60760-0925-30 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0283 | 55154-0283-00 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Coupler LLC | 67046-1076 | 67046-1076-03 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Coupler LLC | 67046-0663 | 67046-0663-03 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Coupler LLC | 67046-0843 | 67046-0843-03 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4112 | 68788-4112-0168788-4112-0368788-4112-06+1 more |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Safecor Health, LLC | 48433-006 | 48433-0006-20 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Safecor Health, LLC | 48433-004 | 48433-0004-20 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Safecor Health, LLC | 48433-005 | 48433-0005-20 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8834 | 68788-8834-0168788-8834-0368788-8834-06+1 more |
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 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 | Cardinal Health 107, LLC | 55154-0283 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | direct rx | 72189-146 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-736 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0757 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Proficient Rx LP | 71205-496 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-658 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-684 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-685 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Mylan Institutional Inc. | 51079-759 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-834 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-986 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-491 |
| 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 | Golden State Medical Supply, Inc. | 60429-027 |
| 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 |
Showing 20 of 21.