NDC codes

FDA NDC Directory
Product NDC (as listed)64850-893Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64850-0893Add 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 NDC11-digit (billing)PackageCopy
64850-893-016485008930164850089301100 CAPSULE in 1 BOTTLE (64850-893-01)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 — 50 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
Listing expires
Identifiers
Product ID 64850-893_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

N464850089301 followed by a unit qualifier and the quantity

Package 64850-0893-01. 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 . 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 64850-893

What is NDC 64850-893?
64850-893 is the product NDC for Loxapine, Loxapine succinate 50 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LoxapineLoxapine succinate 50 mg/1CapsuleOralREMEDYREPACK INC.70518-431170518-4311-00
LoxapineLoxapine succinate 25 mg/1CapsuleOralCoupler LLC67046-147867046-1478-03
LoxapineLoxapine succinate 5 mg/1CapsuleOralCoupler LLC67046-147967046-1479-03
LoxapineLoxapine succinate 10 mg/1CapsuleOralCoupler LLC67046-148567046-1485-03
LoxapineLoxapine succinate 5 mg/1CapsuleOralElite Laboratories, Inc.64850-89064850-0890-01
LoxapineLoxapine succinate 10 mg/1CapsuleOralElite Laboratories, Inc.64850-89164850-0891-01
LoxapineLoxapine succinate 25 mg/1CapsuleOralElite Laboratories, Inc.64850-89264850-0892-01
LoxapineLoxapine succinate 25 mg/1CapsuleOralREMEDYREPACK INC.70518-189670518-1896-00
LoxapineLoxapine succinate 50 mg/1CapsuleOralREMEDYREPACK INC.70518-179270518-1792-0070518-1792-01
LoxapineLoxapine succinate 10 mg/1CapsuleOralREMEDYREPACK INC.70518-168170518-1681-00

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
ProductStrengthForm · routeLabelerProduct NDC
LoxapineLoxapine succinate 5 mg/1CapsuleOralElite Laboratories, Inc.64850-890
LoxapineLoxapine succinate 10 mg/1CapsuleOralElite Laboratories, Inc.64850-891
LoxapineLoxapine succinate 25 mg/1CapsuleOralElite Laboratories, Inc.64850-892
LoxapineLoxapine succinate 50 mg/1CapsuleOralREMEDYREPACK INC.70518-4311

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