Metoprolol Tartrate and Hydrochlorothiazide NDC 0378-0424

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0424Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0424Add 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
0378-0424-01	00378042401	100 TABLET in 1 BOTTLE, PLASTIC (0378-0424-01)Marketed from Aug 20, 2004

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 and Hydrochlorothiazide
Generic name (nonproprietary): metoprolol tartrate and hydrochlorothiazide
Active ingredients: Metoprolol tartrate — 50 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076792
Marketing start: Aug 20, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 0378-0424_771d61ce-0810-4998-b77b-9d3fe58056d9SPL ID 771d61ce-0810-4998-b77b-9d3fe58056d9SPL set ID b6cf0f43-8dc3-4535-b651-daf1f9e0336cRxCUI 866479, 866482, 866491UNII W5S57Y3A5L, 0J48LPH2THUPC 0303780434011, 0303780424012, 0303780445017
Pharmacologic class: Thiazide Diuretic; 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

N400378042401 followed by a unit qualifier and the quantity

Package 00378-0424-01. 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 Jan 15, 2024.

Indications (excerpt from the label)

Metoprolol tartrate and hydrochlorothiazide 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 achieve blood…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076792

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

FDA NDC Directory listings under ANDA 076792
Product	Strength	Form · route	Labeler	Product NDC
Metoprolol Tartrate and Hydrochlorothiazide	Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0434
Metoprolol Tartrate and Hydrochlorothiazide	Metoprolol tartrate 100 mg/1; Hydrochlorothiazide 50 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0445