What is NDC 68083-138?

68083-138 is the product NDC for Haloperidol Decanoate, Haloperidol decanoate 100 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Haloperidol Decanoate?

55 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Haloperidol Decanoate NDC 68083-138

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-138Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0138Add 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
68083-138-02	6808301380268083013802	1 VIAL in 1 CARTON (68083-138-02) / 5 mL in 1 VIALMarketed from Jan 16, 2017
68083-138-10	6808301381068083013810	10 VIAL in 1 CARTON (68083-138-10) / 1 mL in 1 VIALMarketed from Jan 16, 2017

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): Haloperidol Decanoate
Generic name (nonproprietary): haloperidol decanoate
Active ingredients: Haloperidol decanoate — 100 mg/mL
Dosage form: Injection
Route: Intramuscular
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205241
Marketing start: Jan 16, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 68083-138_09213604-f576-4578-ad34-92b448e3c782SPL ID 09213604-f576-4578-ad34-92b448e3c782SPL set ID 1a0e38cb-fd9f-4962-9f81-5c0023ca6b4cRxCUI 859867, 859871, 1719803, 1719862UNII AC20PJ4101UPC 0368083137106, 0368083138103
Pharmacologic class: Typical Antipsychotic

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083013802 followed by a unit qualifier and the quantity

Package 68083-0138-02. 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 Jul 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product. Haloperidol decanoate injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-138

What is NDC 68083-138?: 68083-138 is the product NDC for Haloperidol Decanoate, Haloperidol decanoate 100 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Haloperidol Decanoate.
What is the active ingredient?: Haloperidol decanoate.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Haloperidol Decanoate?: 55 other product NDCs are listed under this name. See all Haloperidol Decanoate 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 Haloperidol Decanoate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Haloperidol Decanoate	Haloperidol decanoate 50 mg/mL	InjectionIntramuscular	REMEDYREPACK INC.	70518-4670	70518-4670-00
Haloperidol Decanoate	Haloperidol decanoate 50 mg/mL	InjectionIntramuscular	Armas Pharmaceuticals Inc.	72485-520	72485-0520-10
Haloperidol Decanoate	Haloperidol decanoate 100 mg/mL	InjectionIntramuscular	Armas Pharmaceuticals Inc.	72485-521	72485-0521-10
Haloperidol Decanoate	Haloperidol decanoate 500 mg/5mL	InjectionIntramuscular	Armas Pharmaceuticals Inc.	72485-522	72485-0522-01
Haloperidol Decanoate	Haloperidol decanoate 100 mg/mL	InjectionIntramuscular	REMEDYREPACK INC.	70518-4584	70518-4584-00
Haloperidol Decanoate	Haloperidol decanoate 50 mg/mL	InjectionIntramuscular	Somerset Therapeutics, LLC	70069-866	70069-0866-10
Haloperidol Decanoate	Haloperidol decanoate 100 mg/mL	InjectionIntramuscular	Somerset Therapeutics, LLC	70069-867	70069-0867-05
Haloperidol Decanoate	Haloperidol decanoate 100 mg/mL	InjectionIntramuscular	Somerset Therapeutics, LLC	70069-868	70069-0868-01
Haloperidol decanoate	Haloperidol decanoate 50 mg/mL	InjectionIntramuscular	BluePoint Laboratories	68001-657	68001-0657-51
Haloperidol decanoate	Haloperidol decanoate 100 mg/mL	InjectionIntramuscular	BluePoint Laboratories	68001-658	68001-0658-4168001-0658-52

All 56 Haloperidol Decanoate NDCs

Other NDCs under ANDA 205241

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

FDA NDC Directory listings under ANDA 205241
Product	Strength	Form · route	Labeler	Product NDC
haloperidol decanoate	Haloperidol decanoate 50 mg/mL	Injection, SolutionIntramuscular	Sagent Pharmaceuticals	25021-831
haloperidol decanoate	Haloperidol decanoate 100 mg/mL	Injection, SolutionIntramuscular	Sagent Pharmaceuticals	25021-833
haloperidol decanoate	Haloperidol decanoate 500 mg/5mL	Injection, SolutionIntramuscular	Sagent Pharmaceuticals	25021-834
Haloperidol Decanoate	Haloperidol decanoate 50 mg/mL	InjectionIntramuscular	Gland Pharma Limited	68083-137