NDC codes

FDA NDC Directory
Product NDC (as listed)49884-347Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49884-0347Add 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
49884-347-0149884034701100 TABLET in 1 BOTTLE (49884-347-01)Marketed from Sep 28, 2015

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)
Pimozide
Generic name (nonproprietary)
pimozide
Active ingredients
Pimozide — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Par Health USA, LLCNDC labeler code 49884
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204521
Marketing start
Listing expires
Identifiers
Product ID 49884-347_a3c5958c-a773-4d10-ae80-9cd453bf07feSPL ID a3c5958c-a773-4d10-ae80-9cd453bf07feSPL set ID 70b079e2-a1f7-4a93-8685-d60a4d7c1280RxCUI 198103, 312439UNII 1HIZ4DL86FUPC 0349884347017, 0349884348014
Pharmacologic class
Typical Antipsychotic

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

N449884034701 followed by a unit qualifier and the quantity

Package 49884-0347-01. 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 Pimozide tablets, USP are indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment. Pimozide tablets, USP are not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide tablets, USP should be reserved for use in Tourette’s Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics. Evidence supporting approval of pimozide tablets, USP for use in Tourette’s Disorder was obtained in two controlled clinical investiga…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49884-347

What is NDC 49884-347?
49884-347 is the product NDC for Pimozide, Pimozide 1 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pimozide.
What is the active ingredient?
Pimozide.
Who is the labeler?
Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pimozide?
3 other product NDCs are listed under this name. See all Pimozide 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 Pimozide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PimozidePimozide 1 mg/1TabletOralANI Pharmaceuticals, Inc.70954-85370954-0853-10
PimozidePimozide 2 mg/1TabletOralANI Pharmaceuticals, Inc.70954-85470954-0854-10
PimozidePimozide 2 mg/1TabletOralPar Health USA, LLC49884-34849884-0348-01

Other NDCs under ANDA 204521

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

FDA NDC Directory listings under ANDA 204521
ProductStrengthForm · routeLabelerProduct NDC
PimozidePimozide 2 mg/1TabletOralPar Health USA, LLC49884-348

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