What is NDC 67046-1478?

67046-1478 is the product NDC for Loxapine, Loxapine succinate 25 mg/1 capsule, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Loxapine?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loxapine NDC 67046-1478 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1478Add 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
67046-1478-3	6704614780367046147803	30 CAPSULE in 1 BLISTER PACK (67046-1478-3)Marketed from Jan 30, 2025

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): Loxapine
Generic name (nonproprietary): loxapine
Active ingredients: Loxapine succinate — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090695
Marketing start: Jan 30, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 67046-1478_2cf84def-bf5d-9564-e063-6394a90a9b03SPL ID 2cf84def-bf5d-9564-e063-6394a90a9b03SPL set ID 2cf85ba7-7b62-6519-e063-6394a90a32c4RxCUI 311385UNII X59SG0MRYU

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

N467046147803 followed by a unit qualifier and the quantity

Package 67046-1478-03. 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 Jan 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1478

What is NDC 67046-1478?: 67046-1478 is the product NDC for Loxapine, Loxapine succinate 25 mg/1 capsule, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loxapine.
What is the active ingredient?: Loxapine succinate.
Who is the labeler?: Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loxapine?: 21 other product NDCs are listed under this name. See all Loxapine 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 Loxapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4311	70518-4311-00
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Coupler LLC	67046-1479	67046-1479-03
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	Coupler LLC	67046-1485	67046-1485-03
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-890	64850-0890-01
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-891	64850-0891-01
Loxapine	Loxapine succinate 25 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-892	64850-0892-01
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-893	64850-0893-01
Loxapine	Loxapine succinate 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1896	70518-1896-00
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1792	70518-1792-0070518-1792-01
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1681	70518-1681-00

All 22 Loxapine NDCs

Other NDCs under ANDA 090695

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

FDA NDC Directory listings under ANDA 090695
Product	Strength	Form · route	Labeler	Product NDC
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1394
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1395
Loxapine	Loxapine succinate 25 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1396
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1397
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Chartwell RX, LLC	62135-492
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	Chartwell RX, LLC	62135-493
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Coupler LLC	67046-1479
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	Coupler LLC	67046-1485
Loxapine	Loxapine succinate 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1681
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1792
Loxapine	Loxapine succinate 25 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1896
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Proficient Rx LP	82804-051