Prescription drug · ANDA

Prochlorperazine Maleate NDC 59746-115

Prochlorperazine maleate 10 mg/1 · Tablet · Oral · Jubilant Cadista Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)59746-115Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59746-0115Add 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
59746-115-065974601150659746011506100 TABLET in 1 BOTTLE (59746-115-06)Marketed from Mar 1, 1998
59746-115-1059746011510597460115101000 TABLET in 1 BOTTLE (59746-115-10)Marketed from Mar 1, 1998

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)
Prochlorperazine Maleate
Generic name (nonproprietary)
prochlorperazine maleate
Active ingredients
Prochlorperazine maleate — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Jubilant Cadista Pharmaceuticals Inc.NDC labeler code 59746
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040268
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 59746-115_15ccaf96-5c2f-45cb-992c-99f5458da55bSPL ID 15ccaf96-5c2f-45cb-992c-99f5458da55bSPL set ID b05bc20e-cd19-ab40-1ad0-84a115d6d69eRxCUI 198365, 312635UNII I1T8O1JTL6UPC 0359746113063, 0359746115067
Pharmacologic class
Phenothiazine

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

N459746011506 followed by a unit qualifier and the quantity

Package 59746-0115-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59746-115

What is NDC 59746-115?
59746-115 is the product NDC for Prochlorperazine Maleate, Prochlorperazine maleate 10 mg/1 tablet, listed with the FDA by Jubilant Cadista Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Prochlorperazine Maleate.
What is the active ingredient?
Prochlorperazine maleate.
Who is the labeler?
Jubilant Cadista Pharmaceuticals Inc., NDC labeler code 59746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prochlorperazine Maleate?
61 other product NDCs are listed under this name. See all Prochlorperazine Maleate 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 Prochlorperazine Maleate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
prochlorperazine maleateProchlorperazine maleate 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-472870518-4728-00
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralREMEDYREPACK INC.70518-449870518-4498-00
prochlorperazine maleateProchlorperazine maleate 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-77359651-0773-01
prochlorperazine maleateProchlorperazine maleate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-77459651-0774-01
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-51772789-0517-0172789-0517-90
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-51872789-0518-0172789-0518-1572789-0518-90
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1Tablet, Film coatedOralLeading Pharma, LLC69315-26569315-0265-01
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1Tablet, Film coatedOralLeading Pharma, LLC69315-26669315-0266-01
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralGLENMARK PHARMACEUTICALS INC., USA68462-94768462-0947-0168462-0947-10
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralREMEDYREPACK INC.70518-431970518-4319-00

All 62 Prochlorperazine Maleate NDCs

Other NDCs under ANDA 040268

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

FDA NDC Directory listings under ANDA 040268
ProductStrengthForm · routeLabelerProduct NDC
ProchlorperazineProchlorperazine maleate 5 mg/1TabletOralPharmPak, Inc.54348-989
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralQPharma, Inc.42708-103
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-742
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralA-S Medication Solutions50090-2839
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralAvPAK50268-684
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralAvPAK50268-685
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralNorthwind Health Company, LLC51655-096
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralNorthwind Health Company, LLC51655-330
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralCardinal Health 107, LLC55154-4342
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-113
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralProficient Rx LP63187-251
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralProficient Rx LP63187-502
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-271
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralREMEDYREPACK INC.70518-1620
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralBryant Ranch Prepack71335-0952
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralBryant Ranch Prepack72162-2262
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralDirect_Rx72189-503
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1TabletOralSportpharm LLC85766-232
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1TabletOralSportpharm LLC85766-233

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