Prescription drug · ANDA

Metoprolol Tartrate (Metoprolol) NDC 0615-8422

Metoprolol tartrate 50 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8422Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8422Add 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
0615-8422-05006158422050061584220515 TABLET in 1 BLISTER PACK (0615-8422-05)Marketed from Feb 8, 2022
0615-8422-39006158422390061584223930 TABLET in 1 BLISTER PACK (0615-8422-39)Marketed from Feb 8, 2022

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)
Metoprolol Tartrate
Generic name (nonproprietary)
metoprolol
Active ingredients
Metoprolol tartrate — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202871
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 0615-8422_d1fcc391-6fd0-4240-b53d-83262763d0e4SPL ID d1fcc391-6fd0-4240-b53d-83262763d0e4SPL set ID c97e7527-b44e-48ca-b6be-53999bf5554bRxCUI 866511, 866514, 866924UNII W5S57Y3A5L
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

N400615842205 followed by a unit qualifier and the quantity

Package 00615-8422-05. 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)

Metoprolol tartrate tablet is a beta-adrenergic blocker 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 ) • Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8422

What is NDC 0615-8422?
0615-8422 is the product NDC for Metoprolol Tartrate (metoprolol), Metoprolol tartrate 50 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metoprolol Tartrate (Metoprolol).
What is the active ingredient?
Metoprolol tartrate.
Who is the labeler?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Tartrate?
224 other product NDCs are listed under this name. See all Metoprolol Tartrate 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 Tartrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-94460760-0944-60
Metoprolol TartrateMetoprolol tartrate 100 mg/1TabletOralREMEDYREPACK INC.70518-474870518-4748-00
Metoprolol TartrateMetoprolol tartrate 25 mg/1TabletOralREMEDYREPACK INC.70518-471470518-4714-00
Metoprolol TartrateMetoprolol tartrate 50 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-027855154-0278-00
Metoprolol TartrateMetoprolol tartrate 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-027955154-0279-00
Metoprolol TartrateMetoprolol tartrate 50 mg/1TabletOralDirect_Rx72189-67772189-0677-90
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralCoupler LLC67046-138467046-1384-03
Metoprolol TartrateMetoprolol tartrate 100 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-92860760-0928-90
Metoprolol TartrateMetoprolol tartrate 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-55572789-0555-90
Metoprolol TartrateMetoprolol tartrate 25 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-07348433-0073-20

All 225 Metoprolol Tartrate NDCs

Other NDCs under ANDA 202871

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

FDA NDC Directory listings under ANDA 202871
ProductStrengthForm · routeLabelerProduct NDC
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8421
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8423
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralAlembic Pharmaceuticals Limited46708-290
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralAlembic Pharmaceuticals Limited46708-291
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralAlembic Pharmaceuticals Limited46708-292
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralA-S Medication Solutions50090-8092
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-944
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-112
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-113
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-114
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralCoupler LLC67046-1384
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralRedpharm Drug67296-2323
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3942
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralREMEDYREPACK INC.70518-3506
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralREMEDYREPACK INC.70518-4418
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralProficient Rx LP71205-003
Metoprolol TartratemetoprololMetoprolol tartrate 100 mg/1TabletOralBryant Ranch Prepack71335-3159
Metoprolol TartratemetoprololMetoprolol tartrate 25 mg/1TabletOralNorthwind Health Company, LLC82868-037
Metoprolol TartratemetoprololMetoprolol tartrate 50 mg/1TabletOralNorthwind Health Company, LLC82868-090

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