What is NDC 62756-956?

62756-956 is the product NDC for Mexiletine Hydrochloride, Mexiletine hydrochloride 200 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mexiletine Hydrochloride?

47 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mexiletine Hydrochloride NDC 62756-956

NDC codes

FDA NDC Directory

Product NDC (as listed)62756-956Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62756-0956Add 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
62756-956-01	6275609560162756095601	100 CAPSULE in 1 BOTTLE (62756-956-01)Marketed from Nov 29, 2021

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): Mexiletine Hydrochloride
Generic name (nonproprietary): mexiletine hydrochloride
Active ingredients: Mexiletine hydrochloride — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214089
Marketing start: Nov 29, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 62756-956_7bb96934-8c07-463e-b96e-cafaafb8d2dcSPL ID 7bb96934-8c07-463e-b96e-cafaafb8d2dcSPL set ID 2d0c61ca-4c99-42f9-8f00-e0e9d2672a39RxCUI 1362706, 1362712, 1362720UNII 606D60IS38
Pharmacologic class: Antiarrhythmic

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

N462756095601 followed by a unit qualifier and the quantity

Package 62756-0956-01. 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 Apr 27, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmia…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62756-956

What is NDC 62756-956?: 62756-956 is the product NDC for Mexiletine Hydrochloride, Mexiletine hydrochloride 200 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mexiletine Hydrochloride.
What is the active ingredient?: Mexiletine hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mexiletine Hydrochloride?: 47 other product NDCs are listed under this name. See all Mexiletine 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 Mexiletine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Amerisyn LLC	87564-052	87564-0052-10
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Amerisyn LLC	87564-053	87564-0053-10
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Amerisyn LLC	87564-054	87564-0054-10
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-555	33342-0555-1133342-0555-12
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-556	33342-0556-1133342-0556-12
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-557	33342-0557-1133342-0557-12
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-666	64980-0666-01
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-667	64980-0667-01
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	64980-668	64980-0668-01
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-3171	71335-3171-0171335-3171-02

All 48 Mexiletine Hydrochloride NDCs

Other NDCs under ANDA 214089

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

FDA NDC Directory listings under ANDA 214089
Product	Strength	Form · route	Labeler	Product NDC
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	62756-955
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	62756-957
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9179
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9180
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-9181
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2922
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2928
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1782
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1783
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1784
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Senores Pharmaceuticals, Inc.	82012-028
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Senores Pharmaceuticals, Inc.	82012-029
Mexiletine Hydrochloride	Mexiletine hydrochloride 150 mg/1	CapsuleOral	Amerisyn LLC	87564-052
Mexiletine Hydrochloride	Mexiletine hydrochloride 200 mg/1	CapsuleOral	Amerisyn LLC	87564-053
Mexiletine Hydrochloride	Mexiletine hydrochloride 250 mg/1	CapsuleOral	Amerisyn LLC	87564-054