What is NDC 0378-6380?

0378-6380 is the product NDC for Verapamil Hydrochloride, Verapamil hydrochloride 180 mg/1 capsule, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Verapamil Hydrochloride?

131 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Verapamil Hydrochloride NDC 0378-6380

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6380Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6380Add 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
0378-6380-01	0037863800100378638001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6380-01)Marketed from May 20, 1999

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): Verapamil Hydrochloride
Generic name (nonproprietary): verapamil hydrochloride
Active ingredients: Verapamil hydrochloride — 180 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075138
Marketing start: May 20, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0378-6380_c63ca9bc-5c77-4e53-8adf-9cfd16bfe012SPL ID c63ca9bc-5c77-4e53-8adf-9cfd16bfe012SPL set ID c86084bc-33aa-eece-5a96-6c0dad2d1a32RxCUI 897612, 897618, 897624UNII V3888OEY5RUPC 0303786380015, 0303786320011, 0303786440016
Pharmacologic class: Calcium Channel 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

N400378638001 followed by a unit qualifier and the quantity

Package 00378-6380-01. 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 Jun 21, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 this drug. 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-6380

What is NDC 0378-6380?: 0378-6380 is the product NDC for Verapamil Hydrochloride, Verapamil hydrochloride 180 mg/1 capsule, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Verapamil Hydrochloride.
What is the active ingredient?: Verapamil hydrochloride.
Who is the labeler?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Verapamil Hydrochloride?: 131 other product NDCs are listed under this name. See all Verapamil Hydrochloride 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 Verapamil Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Verapamil hydrochloride	Verapamil hydrochloride 120 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1953	70771-1953-0170771-1953-05
Verapamil hydrochloride	Verapamil hydrochloride 180 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1954	70771-1954-0170771-1954-05
Verapamil hydrochloride	Verapamil hydrochloride 240 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1955	70771-1955-0170771-1955-05
Verapamil hydrochloride	Verapamil hydrochloride 120 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-561	68382-0561-0168382-0561-05
Verapamil hydrochloride	Verapamil hydrochloride 180 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-562	68382-0562-0168382-0562-05
Verapamil hydrochloride	Verapamil hydrochloride 240 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-563	68382-0563-0168382-0563-05
Verapamil Hydrochloride	Verapamil hydrochloride 120 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-145	48433-0145-20
Verapamil Hydrochloride	Verapamil hydrochloride 180 mg/1	TabletOral	REMEDYREPACK INC.	70518-4513	70518-4513-00
Verapamil Hydrochloride	Verapamil hydrochloride 2.5 mg/mL	Injection, SolutionIntravenous	REMEDYREPACK INC.	70518-4453	70518-4453-00
Verapamil Hydrochloride	Verapamil hydrochloride 2.5 mg/mL	Injection, SolutionIntravenous	Caplin Steriles Limited	65145-114	65145-0114-05

All 132 Verapamil Hydrochloride NDCs

Other NDCs under ANDA 075138

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

FDA NDC Directory listings under ANDA 075138
Product	Strength	Form · route	Labeler	Product NDC
Verapamil Hydrochloride	Verapamil hydrochloride 120 mg/1	Capsule, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-6320
Verapamil Hydrochloride	Verapamil hydrochloride 240 mg/1	Capsule, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-6440
Verapamil Hydrochloride	Verapamil hydrochloride 120 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-145
Verapamil Hydrochloride	Verapamil hydrochloride 120 mg/1	Capsule, Extended releaseOral	Mylan Institutional Inc.	51079-917