NDC codes

FDA NDC Directory
Product NDC (as listed)62135-785Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0785Add 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
62135-785-90621350785906213507859090 CAPSULE in 1 BOTTLE (62135-785-90)Marketed from Oct 25, 2023

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 — 250 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213500
Marketing start
Listing expires
Identifiers
Product ID 62135-785_462a5c01-c4ca-6bfa-e063-6294a90a4dd9SPL ID 462a5c01-c4ca-6bfa-e063-6294a90a4dd9SPL set ID 4e03e02f-c516-479e-9126-86b0df7f8b1cRxCUI 1362720UNII 606D60IS38UPC 0362135785901
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

N462135078590 followed by a unit qualifier and the quantity

Package 62135-0785-90. 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)

INDICATIONS AND USAGE Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement 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 arrhythmias.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-785

What is NDC 62135-785?
62135-785 is the product NDC for Mexiletine Hydrochloride, Mexiletine hydrochloride 250 mg/1 capsule, listed with the FDA by Chartwell RX, LLC. 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?
Chartwell RX, LLC, NDC labeler code 62135. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralAmerisyn LLC87564-05287564-0052-10
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralAmerisyn LLC87564-05387564-0053-10
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralAmerisyn LLC87564-05487564-0054-10
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-55533342-0555-1133342-0555-12
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-55633342-0556-1133342-0556-12
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-55733342-0557-1133342-0557-12
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-66664980-0666-01
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-66764980-0667-01
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralRising Pharma Holdings, Inc.64980-66864980-0668-01
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralBryant Ranch Prepack71335-317171335-3171-0171335-3171-02

All 48 Mexiletine Hydrochloride NDCs

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