NDC codes

FDA NDC Directory
Product NDC (as listed)60219-2038Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60219-2038Add 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
60219-2038-16021920380160219203801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1)Marketed from Apr 21, 2023
60219-2038-760219203807602192038071000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7)Marketed from Apr 21, 2023

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 60219
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216598
Marketing start
Listing expires
Other FDA classes
Phenothiazines (Chemical structure)
Identifiers
Product ID 60219-2038_837acc51-8896-4b6f-8809-ee664e9f0a6aSPL ID 837acc51-8896-4b6f-8809-ee664e9f0a6aSPL set ID a2a48790-0634-4b46-b362-98b7c252836fRxCUI 198365, 312635UNII 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

N460219203801 followed by a unit qualifier and the quantity

Package 60219-2038-01. 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 maleate tablets are effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are 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 maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60219-2038

What is NDC 60219-2038?
60219-2038 is the product NDC for prochlorperazine maleate, Prochlorperazine maleate 5 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?
Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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 216598

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

FDA NDC Directory listings under ANDA 216598
ProductStrengthForm · routeLabelerProduct NDC
prochlorperazine maleateProchlorperazine maleate 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC60219-2039
Prochlorperazine MaleateProchlorperazine maleate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-814
Prochlorperazine MaleateProchlorperazine maleate 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-825

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