NDC codes

FDA NDC Directory
Product NDC (as listed)80705-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80705-0101Add 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
80705-101-02807050101021 BLISTER PACK in 1 CARTON (80705-101-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 29, 2021
80705-101-308070501013030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-101-30)Marketed from Feb 12, 2021
80705-101-99807050101991 BLISTER PACK in 1 CARTON (80705-101-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 12, 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)
Elepsia XR 1500 Mg
Generic name (nonproprietary)
levetiracetam
Active ingredients
Levetiracetam — 1500 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
TRIPOINT THERAPEUTICS, LLCNDC labeler code 80705
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 204417
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 80705-101_3c463bee-1191-4cab-b4d0-367673db19efSPL ID 3c463bee-1191-4cab-b4d0-367673db19efSPL set ID cac83d47-88a2-4447-a0c0-90b44ffda0acRxCUI 1605362, 1605368, 1605372, 1605374UNII 44YRR34555UPC 0380705101302, 0380705100305

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

N480705010102 followed by a unit qualifier and the quantity

Package 80705-0101-02. 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)

ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80705-101

What is NDC 80705-101?
80705-101 is the product NDC for Elepsia XR 1500 Mg (levetiracetam), Levetiracetam 1500 mg/1 tablet, extended release, listed with the FDA by TRIPOINT THERAPEUTICS, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Elepsia XR 1500 Mg (Levetiracetam).
What is the active ingredient?
Levetiracetam.
Who is the labeler?
TRIPOINT THERAPEUTICS, LLC, NDC labeler code 80705. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Elepsia XR 1500 Mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 204417

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

FDA NDC Directory listings under NDA 204417
ProductStrengthForm · routeLabelerProduct NDC
Elepsia XR 1000 MglevetiracetamLevetiracetam 1000 mg/1Tablet, Extended releaseOralTRIPOINT THERAPEUTICS, LLC80705-100

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