What is NDC 54348-989?

54348-989 is the product NDC for Prochlorperazine, Prochlorperazine maleate 5 mg/1 tablet, listed with the FDA by PharmPak, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

PharmPak, Inc., NDC labeler code 54348. 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?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prochlorperazine NDC 54348-989 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-989Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0989Add 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
54348-989-06	5434809890654348098906	1 BOTTLE in 1 BOX (54348-989-06) / 6 TABLET in 1 BOTTLEMarketed from Jul 11, 2019

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
Generic name (nonproprietary): prochlorperazine
Active ingredients: Prochlorperazine maleate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: PharmPak, Inc.NDC labeler code 54348
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040268
Marketing start: Jul 11, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 54348-989_eaa6022b-bb02-9383-e053-2995a90abe88SPL ID eaa6022b-bb02-9383-e053-2995a90abe88SPL set ID 383744db-ba57-478a-8041-2ecc26d3e1ecRxCUI 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

N454348098906 followed by a unit qualifier and the quantity

Package 54348-0989-06. 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 Oct 9, 2022. 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 54348-989

What is NDC 54348-989?: 54348-989 is the product NDC for Prochlorperazine, Prochlorperazine maleate 5 mg/1 tablet, listed with the FDA by PharmPak, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prochlorperazine.
What is the active ingredient?: Prochlorperazine maleate.
Who is the labeler?: PharmPak, Inc., NDC labeler code 54348. 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?: 1 other product NDC are listed under this name. See all Prochlorperazine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prochlorperazine	Prochlorperazine 25 mg/1	SuppositoryRectal	Cosette Pharmaceuticals, Inc.	0713-0135	00713-0135-1000713-0135-12

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
Product	Strength	Form · route	Labeler	Product NDC
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	QPharma, Inc.	42708-103
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-742
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	A-S Medication Solutions	50090-2839
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	AvPAK	50268-684
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	AvPAK	50268-685
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-096
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-330
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-4342
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-113
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Jubilant Cadista Pharmaceuticals Inc.	59746-115
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Proficient Rx LP	63187-251
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	Proficient Rx LP	63187-502
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	66267-271
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-1620
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0952
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Bryant Ranch Prepack	72162-2262
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Direct_Rx	72189-503
Prochlorperazine Maleate	Prochlorperazine maleate 5 mg/1	TabletOral	Sportpharm LLC	85766-232
Prochlorperazine Maleate	Prochlorperazine maleate 10 mg/1	TabletOral	Sportpharm LLC	85766-233