Prescription drug · ANDA

Metoprolol Succinate ER (Metoprolol succinate) NDC 61919-754

Metoprolol succinate 25 mg/1 · Tablet, Extended release · Oral · Direct_Rx

NDC codes

FDA NDC Directory
Product NDC (as listed)61919-754Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0754Add 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 NDC11-digit (billing)PackageCopy
61919-754-30619190754306191907543030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-754-30)Marketed from May 2, 2019
61919-754-90619190754906191907549090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-754-90)Marketed from May 2, 2019

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)
Metoprolol Succinate ERSuffix: ER
Generic name (nonproprietary)
metoprolol succinate
Active ingredients
Metoprolol succinate — 25 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Direct_RxNDC labeler code 61919
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204106
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 61919-754_0e993203-3e65-5fbd-e063-6294a90a0636SPL ID 0e993203-3e65-5fbd-e063-6294a90a0636SPL set ID 7ea78d2a-aa9f-38d4-e053-2991aa0a07feRxCUI 866412, 866427UNII 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

N461919075430 followed by a unit qualifier and the quantity

Package 61919-0754-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

1.1 Hypertension Metoprolol succinate extended-release 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 metoprolol. 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 ac…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-754

What is NDC 61919-754?
61919-754 is the product NDC for Metoprolol Succinate ER (metoprolol succinate), Metoprolol succinate 25 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metoprolol Succinate ER (Metoprolol succinate).
What is the active ingredient?
Metoprolol succinate.
Who is the labeler?
Direct_Rx, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metoprolol Succinate ER?
2 other product NDCs are listed under this name. See all Metoprolol Succinate ER 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 Metoprolol Succinate ER NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metoprolol Succinate ERMetoprolol succinate 25 mg/1Tablet, Film coated, Extended releaseOralDIrect_Rx72189-65272189-0652-90
Metoprolol Succinate ERMetoprolol succinate 50 mg/1Tablet, Extended releaseOralDirect_Rx72189-54772189-0547-90

Other NDCs under ANDA 204106

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

FDA NDC Directory listings under ANDA 204106
ProductStrengthForm · routeLabelerProduct NDC
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-615
Metoprolol SuccinateMetoprolol succinate 50 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-616
Metoprolol SuccinateMetoprolol succinate 100 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-617
Metoprolol SuccinateMetoprolol succinate 200 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-618
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-403
Metoprolol SuccinateMetoprolol succinate 50 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-404
Metoprolol SuccinateMetoprolol succinate 100 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-405
Metoprolol SuccinateMetoprolol succinate 200 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-406
Metoprolol SuccinateMetoprolol succinate 50 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-203
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralCoupler LLC67046-0883
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-356
Metoprolol SuccinateMetoprolol succinate 100 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-358
Metoprolol SuccinateMetoprolol succinate 200 mg/1Tablet, Extended releaseOralBluePoint Laboratories68001-360
Metoprolol SuccinateMetoprolol succinate 50 mg/1Tablet, Extended releaseOralProficient Rx LP71205-179
Metoprolol SuccinateMetoprolol succinate 100 mg/1Tablet, Extended releaseOralProficient Rx LP71205-336
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralProficient Rx LP71205-350
Metoprolol SuccinateMetoprolol succinate 25 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-555
Metoprolol SuccinateMetoprolol succinate 100 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-558
Metoprolol SuccinateMetoprolol succinate 200 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-573
Metoprolol SuccinateMetoprolol succinate 50 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-642

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