What is NDC 0591-0371?

0591-0371 is the product NDC for Loxapine, Loxapine succinate 25 mg/1 capsule, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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 0591-0371 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-0371Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-0371Add 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
0591-0371-01	0059103710100591037101	100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0371-01)Marketed from Jun 15, 1988

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Loxapine
Generic name (nonproprietary): loxapine
Active ingredients: Loxapine succinate — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072206
Marketing start: Jun 15, 1988
Listing expires: Dec 31, 2026
Identifiers: Product ID 0591-0371_cae2db34-6be2-45cf-b9b5-9b929650eb4fSPL ID cae2db34-6be2-45cf-b9b5-9b929650eb4fSPL set ID a6107bb1-3e23-4c5d-bbf4-5e29deff6728RxCUI 311385, 311386, 314075, 314078UNII X59SG0MRYUUPC 0305910369019, 0305910370015, 0305910372019

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

N400591037101 followed by a unit qualifier and the quantity

Package 00591-0371-01. 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 Mar 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Loxapine capsules 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 0591-0371

What is NDC 0591-0371?: 0591-0371 is the product NDC for Loxapine, Loxapine succinate 25 mg/1 capsule, listed with the FDA by Actavis Pharma, Inc.. 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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 25 mg/1	CapsuleOral	Coupler LLC	67046-1478	67046-1478-03
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

All 22 Loxapine NDCs