NDC codes

FDA NDC Directory
Product NDC (as listed)68118-720Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68118-0720Add 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
68118-720-1068118072010681180720101 VIAL, GLASS in 1 CARTON (68118-720-10) / 1 mL in 1 VIAL, GLASSMarketed from Aug 15, 2019

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)
Prialt
Generic name (nonproprietary)
ziconotide acetate
Active ingredients
Ziconotide acetate — 100 ug/mL
Dosage form
Injection, Solution
Route
Intrathecal
Labeler
ESTEVE PHARMACEUTICALS, S.A.NDC labeler code 68118
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021060
Marketing start
Listing expires
Other FDA classes
N-Calcium Channel Receptor Antagonists (Mechanism)
Identifiers
Product ID 68118-720_5b88b034-162b-73cd-e063-6394a90a7fb3SPL ID 5b88b034-162b-73cd-e063-6394a90a7fb3
Pharmacologic class
N-type Calcium Channel Antagonist

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N468118072010 followed by a unit qualifier and the quantity

Package 68118-0720-10. 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 68118-720

What is NDC 68118-720?
68118-720 is the product NDC for Prialt (ziconotide acetate), Ziconotide acetate 100 ug/mL injection, solution, listed with the FDA by ESTEVE PHARMACEUTICALS, S.A.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Prialt (Ziconotide acetate).
What is the active ingredient?
Ziconotide acetate.
Who is the labeler?
ESTEVE PHARMACEUTICALS, S.A., NDC labeler code 68118. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prialt?
5 other product NDCs are listed under this name. See all Prialt 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 Prialt NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Prialtziconotide acetateZiconotide acetate 500 ug/5mLInjection, SolutionIntrathecalESTEVE PHARMACEUTICALS, S.A.68118-72268118-0722-10
Prialtziconotide acetateZiconotide acetate 500 ug/20mLInjection, SolutionIntrathecalESTEVE PHARMACEUTICALS, S.A.68118-72368118-0723-10
Prialtziconotide acetateZiconotide acetate 100 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-72070720-0720-10
Prialtziconotide acetateZiconotide acetate 100 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-72270720-0722-10
Prialtziconotide acetateZiconotide acetate 25 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-72370720-0723-10

Other NDCs under NDA 021060

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

FDA NDC Directory listings under NDA 021060
ProductStrengthForm · routeLabelerProduct NDC
Prialtziconotide acetateZiconotide acetate 500 ug/5mLInjection, SolutionIntrathecalESTEVE PHARMACEUTICALS, S.A.68118-722
Prialtziconotide acetateZiconotide acetate 500 ug/20mLInjection, SolutionIntrathecalESTEVE PHARMACEUTICALS, S.A.68118-723
Prialtziconotide acetateZiconotide acetate 100 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-720
Prialtziconotide acetateZiconotide acetate 100 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-722
Prialtziconotide acetateZiconotide acetate 25 ug/mLInjection, SolutionIntrathecalTerSera Therapeutics LLC70720-723

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