NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8005Add 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
63629-8005-16362980050190 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8005-1)Marketed from May 9, 2019

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)
Ethosuximide
Generic name (nonproprietary)
ethosuximide
Active ingredients
Ethosuximide — 250 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040430
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 63629-8005_e5905131-91d2-403b-948c-da995b7ebebcSPL ID e5905131-91d2-403b-948c-da995b7ebebcSPL set ID 867b54c4-4ce4-4c00-a03b-f108f1000e29RxCUI 197682UNII 5SEH9X1D1D
Pharmacologic class
Anti-epileptic Agent

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

N463629800501 followed by a unit qualifier and the quantity

Package 63629-8005-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Ethosuximide capsules are indicated for the control of absence (petit mal) epilepsy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040430

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

FDA NDC Directory listings under ANDA 040430
ProductStrengthForm · routeLabelerProduct NDC
EthosuximideEthosuximide 250 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-152

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