Prochlorperazine Maleate NDC 69315-265

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-265Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0265Add 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 NDC	11-digit (billing)	Package	Copy
69315-265-01	69315026501	100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)Marketed from Jun 25, 2025

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Leading Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218912
Marketing start: Jun 25, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532SPL ID e9585ce8-2433-4d85-ab3a-c544d7cb1532SPL set ID c93494ef-c510-4e46-a1b1-362624200223RxCUI 198365, 312635UNII I1T8O1JTL6UPC 0369315265017, 0369315266014
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

N469315026501 followed by a unit qualifier and the quantity

Package 69315-0265-01. 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 Jul 9, 2025. 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)

Other NDCs under ANDA 218912

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

FDA NDC Directory listings under ANDA 218912
Product	Strength	Form · route	Labeler	Product NDC
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	Tablet, Film coatedOral	Leading Pharma, LLC	69315-266
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-517
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-518