Prescription drug · ANDA
Atenolol NDC 68071-4538
Atenolol 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4538-3 | 68071453803 | 30 TABLET in 1 BOTTLE (68071-4538-3)Marketed from Aug 23, 2018 | |
| 68071-4538-5 | 68071453805 | 45 TABLET in 1 BOTTLE (68071-4538-5)Marketed from Aug 23, 2018 | |
| 68071-4538-6 | 68071453806 | 60 TABLET in 1 BOTTLE (68071-4538-6)Marketed from Aug 23, 2018 | |
| 68071-4538-8 | 68071453808 | 180 TABLET in 1 BOTTLE (68071-4538-8)Marketed from Aug 23, 2018 | |
| 68071-4538-9 | 68071453809 | 90 TABLET in 1 BOTTLE (68071-4538-9)Marketed from Aug 23, 2018 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077443
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68071-4538_1a911dea-5bfe-c197-e063-6394a90acda0SPL ID 1a911dea-5bfe-c197-e063-6394a90acda0SPL set ID 741f328d-21a1-3b19-e053-2a91aa0aa327RxCUI 197380UNII 50VV3VW0TIUPC 0368071453898
- 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
N468071453803followed by a unit qualifier and the quantityPackage 68071-4538-03. 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 & USAGE Atenolol 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. 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 goa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077443
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 | Preferred Pharmaceuticals Inc. | 68788-8527 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Direct_Rx | 72189-396 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0954 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-5367 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4527 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | direct rx | 72189-135 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5162 |
| atenolol | Atenolol 100 mg/1 | TabletOral | direct rx | 72189-152 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Proficient Rx LP | 71205-096 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4751 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7535 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1535 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8372 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8373 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-709 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7616 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4553 |
| Atenolol | Atenolol 50 mg/1 | TabletOral | Proficient Rx LP | 71205-229 |
| Atenolol | Atenolol 25 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-437 |
| Atenolol | Atenolol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1264 |
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