Toprol XL (metoprolol succinate) NDC 71610-035

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0035Add 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	Copy
71610-035-45	71610003545	45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-45)Marketed from Jan 26, 2018
71610-035-60	71610003560	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-60)Marketed from Jan 26, 2018

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): Toprol XLSuffix: XL
Generic name (nonproprietary): metoprolol succinate
Active ingredients: Metoprolol succinate — 25 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019962
Marketing start: Jan 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 71610-035_f94f454a-2f40-4d6b-8936-57fad107a20bSPL ID f94f454a-2f40-4d6b-8936-57fad107a20bSPL set ID a07891a5-152e-4a38-8179-e05a90458a7dRxCUI 866427, 866429UNII TH25PD4CCB
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

N471610003545 followed by a unit qualifier and the quantity

Package 71610-0035-45. 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 Feb 20, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

TOPROL-XL, metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) • Angina Pectoris. (1.2) • Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3) 1.1 Hypertension TOPROL-XL 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 m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019962

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

FDA NDC Directory listings under NDA 019962
Product	Strength	Form · route	Labeler	Product NDC
Toprol XLmetoprolol succinate	Metoprolol succinate 50 mg/1	Tablet, Extended releaseOral	Melinta Therapeutics, LLC	70842-111
Toprol XLmetoprolol succinate	Metoprolol succinate 25 mg/1	Tablet, Extended releaseOral	Melinta Therapeutics, LLC	70842-110
Toprol XLmetoprolol succinate	Metoprolol succinate 100 mg/1	Tablet, Extended releaseOral	Melinta Therapeutics, LLC	70842-112
Toprol XLmetoprolol succinate	Metoprolol succinate 200 mg/1	Tablet, Extended releaseOral	Melinta Therapeutics, LLC	70842-113
Metoprolol Succinate	Metoprolol succinate 50 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	71205-162