What is NDC 43353-834?

43353-834 is the product NDC for Atenolol, Atenolol 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atenolol NDC 43353-834 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-834Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0834Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
43353-834-30	4335308343043353083430	30 TABLET in 1 BOTTLE, PLASTIC (43353-834-30)Marketed from Dec 27, 2014
43353-834-45	4335308344543353083445	45 TABLET in 1 BOTTLE, PLASTIC (43353-834-45)Marketed from Nov 18, 2014
43353-834-60	4335308346043353083460	90 TABLET in 1 BOTTLE, PLASTIC (43353-834-60)Marketed from Dec 4, 2014
43353-834-73	4335308347343353083473	135 TABLET in 1 BOTTLE, PLASTIC (43353-834-73)Marketed from Dec 4, 2014
43353-834-80	4335308348043353083480	180 TABLET in 1 BOTTLE, PLASTIC (43353-834-80)Marketed from Nov 18, 2014

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
Generic name (nonproprietary): atenolol
Active ingredients: Atenolol — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073457
Marketing start: Feb 20, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 43353-834_7eca20ff-75cb-402d-942a-7c4854718687SPL ID 7eca20ff-75cb-402d-942a-7c4854718687SPL set ID b02b4be4-b75c-4153-b402-cf330a077439RxCUI 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

N443353083430 followed by a unit qualifier and the quantity

Package 43353-0834-30. 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 Dec 8, 2017. This label includes a boxed warning.

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 nonfatal 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 tablets. 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 one drug to achieve…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-834

What is NDC 43353-834?: 43353-834 is the product NDC for Atenolol, Atenolol 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Atenolol NDCs
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

All 125 Atenolol NDCs

Other NDCs under ANDA 073457

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 073457
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	Mylan Pharmaceuticals Inc.	0378-0231
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 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

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