What is NDC 64850-891?

64850-891 is the product NDC for Loxapine, Loxapine succinate 10 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Elite Laboratories, Inc., NDC labeler code 64850. 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 64850-891 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-891Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0891Add 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
64850-891-01	6485008910164850089101	100 CAPSULE in 1 BOTTLE (64850-891-01)Marketed from Jan 27, 2020

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): Loxapine
Generic name (nonproprietary): loxapine
Active ingredients: Loxapine succinate — 10 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076868
Marketing start: Jan 27, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 64850-891_538b7d03-c464-465d-b690-9701c14cf580SPL ID 538b7d03-c464-465d-b690-9701c14cf580SPL set ID a0cc7bb6-075f-47d1-8935-eb77a29d8c45RxCUI 311385, 311386, 314075, 314078UNII X59SG0MRYUUPC 0364850890014, 0364850893015, 0364850892018, 0364850891011

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

N464850089101 followed by a unit qualifier and the quantity

Package 64850-0891-01. 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 Feb 26, 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 64850-891

What is NDC 64850-891?: 64850-891 is the product NDC for Loxapine, Loxapine succinate 10 mg/1 capsule, listed with the FDA by Elite Laboratories, 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?: Elite Laboratories, Inc., NDC labeler code 64850. 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 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 076868

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

FDA NDC Directory listings under ANDA 076868
Product	Strength	Form · route	Labeler	Product NDC
Loxapine	Loxapine succinate 5 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-890
Loxapine	Loxapine succinate 25 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-892
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-893
Loxapine	Loxapine succinate 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4311