NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2145Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2145Add 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
63629-2145-16362921450163629214501100 CAPSULE in 1 BOTTLE (63629-2145-1)Marketed from Feb 8, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 150 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074450
Marketing start
Listing expires
Identifiers
Product ID 63629-2145_0151c57d-79e6-4416-a9b1-6f34fe442096SPL ID 0151c57d-79e6-4416-a9b1-6f34fe442096SPL set ID c09f68fa-759e-4772-9f6b-11005d8f83d5RxCUI 1362706UNII 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

N463629214501 followed by a unit qualifier and the quantity

Package 63629-2145-01. 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 . This label includes a boxed warning.

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 63629-2145

What is NDC 63629-2145?
63629-2145 is the product NDC for Mexiletine Hydrochloride, Mexiletine hydrochloride 150 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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

Other NDCs under ANDA 074450

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

FDA NDC Directory listings under ANDA 074450
ProductStrengthForm · routeLabelerProduct NDC
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-379
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-380
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-381
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-820
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-821
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralANI Pharmaceuticals, Inc.62559-822
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralBryant Ranch Prepack63629-1963
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralBryant Ranch Prepack63629-1964
Mexiletine HydrochlorideMexiletine hydrochloride 150 mg/1CapsuleOralBryant Ranch Prepack72162-1772
Mexiletine HydrochlorideMexiletine hydrochloride 200 mg/1CapsuleOralBryant Ranch Prepack72162-1773
Mexiletine HydrochlorideMexiletine hydrochloride 250 mg/1CapsuleOralBryant Ranch Prepack72162-1774

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in