NDC codes

FDA NDC Directory
Product NDC (as listed)84054-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84054-0005Add 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
84054-005-148405400051414 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-14)Marketed from Aug 9, 2024 · Sample package
84054-005-608405400056060 TABLET, DELAYED RELEASE in 1 BOTTLE (84054-005-60)Marketed from Aug 9, 2024

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)
Zunveyl
Generic name (nonproprietary)
benzgalantamine
Active ingredients
Benzgalantamine — 5 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Alpha Cognition, Inc.NDC labeler code 84054
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 218549
Marketing start
Listing expires
Identifiers
Product ID 84054-005_20ef23d1-b06c-4087-83ca-bdb9597f2f0cSPL ID 20ef23d1-b06c-4087-83ca-bdb9597f2f0c

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

N484054000514 followed by a unit qualifier and the quantity

Package 84054-0005-14. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 84054-005

What is NDC 84054-005?
84054-005 is the product NDC for Zunveyl (benzgalantamine), Benzgalantamine 5 mg/1 tablet, delayed release, listed with the FDA by Alpha Cognition, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zunveyl (Benzgalantamine).
What is the active ingredient?
Benzgalantamine.
Who is the labeler?
Alpha Cognition, Inc., NDC labeler code 84054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zunveyl?
2 other product NDCs are listed under this name. See all Zunveyl 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 Zunveyl NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZunveylbenzgalantamineBenzgalantamine 10 mg/1Tablet, Delayed releaseOralAlpha Cognition, Inc.84054-01084054-0010-1484054-0010-60
ZunveylbenzgalantamineBenzgalantamine 15 mg/1Tablet, Delayed releaseOralAlpha Cognition, Inc.84054-01584054-0015-60

Other NDCs under NDA 218549

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

FDA NDC Directory listings under NDA 218549
ProductStrengthForm · routeLabelerProduct NDC
ZunveylbenzgalantamineBenzgalantamine 10 mg/1Tablet, Delayed releaseOralAlpha Cognition, Inc.84054-010
ZunveylbenzgalantamineBenzgalantamine 15 mg/1Tablet, Delayed releaseOralAlpha Cognition, Inc.84054-015

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