Prescription drug · ANDA

Prochlorperazine Maleate NDC 71335-0952

Prochlorperazine maleate 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0952Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0952Add 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
71335-0952-1713350952017133509520110 TABLET in 1 BOTTLE (71335-0952-1)Marketed from Mar 14, 2006
71335-0952-2713350952027133509520230 TABLET in 1 BOTTLE (71335-0952-2)Marketed from Mar 14, 2006
71335-0952-3713350952037133509520320 TABLET in 1 BOTTLE (71335-0952-3)Marketed from Mar 14, 2006
71335-0952-4713350952047133509520460 TABLET in 1 BOTTLE (71335-0952-4)Marketed from Mar 14, 2006
71335-0952-571335095205713350952054 TABLET in 1 BOTTLE (71335-0952-5)Marketed from Mar 14, 2006
71335-0952-671335095206713350952065 TABLET in 1 BOTTLE (71335-0952-6)Marketed from Mar 14, 2006
71335-0952-77133509520771335095207100 TABLET in 1 BOTTLE (71335-0952-7)Marketed from Mar 14, 2006
71335-0952-871335095208713350952086 TABLET in 1 BOTTLE (71335-0952-8)Marketed from Mar 14, 2006

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0952_a679eeac-1846-44fc-b6e2-446fb486786bSPL ID a679eeac-1846-44fc-b6e2-446fb486786bSPL set ID 664da979-a480-4482-a5a5-0ec98d4c0037RxCUI 198365UNII I1T8O1JTL6
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

N471335095201 followed by a unit qualifier and the quantity

Package 71335-0952-01. 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 . 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 71335-0952

What is NDC 71335-0952?
71335-0952 is the product NDC for Prochlorperazine Maleate, Prochlorperazine maleate 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-115
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 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

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in