What is NDC 68083-534?

68083-534 is the product NDC for Chlorpromazine hydrochloride, Chlorpromazine hydrochloride 25 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, 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 Chlorpromazine hydrochloride?

106 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Chlorpromazine hydrochloride NDC 68083-534

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-534Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0534Add 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
68083-534-25	6808305342568083053425	25 VIAL in 1 CARTON (68083-534-25) / 2 mL in 1 VIALMarketed from Oct 4, 2024

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): Chlorpromazine hydrochloride
Generic name (nonproprietary): chlorpromazine hydrochloride
Active ingredients: Chlorpromazine hydrochloride — 25 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 216911
Marketing start: Oct 4, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 68083-534_ffd998aa-4c6f-4463-b77c-9dc2e722b948SPL ID ffd998aa-4c6f-4463-b77c-9dc2e722b948SPL set ID 867d5c7f-52d4-4794-b1d4-6747f3262fbaRxCUI 1730076, 1730078UNII 9WP59609J6UPC 0368083534257, 0368083533250
Pharmacologic class: Phenothiazine

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

N468083053425 followed by a unit qualifier and the quantity

Package 68083-0534-25. 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 Oct 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-534

What is NDC 68083-534?: 68083-534 is the product NDC for Chlorpromazine hydrochloride, Chlorpromazine hydrochloride 25 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Chlorpromazine hydrochloride.
What is the active ingredient?: Chlorpromazine hydrochloride.
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 Chlorpromazine hydrochloride?: 106 other product NDCs are listed under this name. See all Chlorpromazine hydrochloride 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 Chlorpromazine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 25 mg/1	Tablet, Sugar coatedOral	American Health Packaging	60687-938	60687-0938-0160687-0938-65
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 50 mg/1	Tablet, Sugar coatedOral	American Health Packaging	60687-949	60687-0949-01
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 100 mg/1	Tablet, Sugar coatedOral	American Health Packaging	60687-960	60687-0960-01
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 200 mg/1	Tablet, Sugar coatedOral	American Health Packaging	60687-971	60687-0971-01
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 100 mg/mL	ConcentrateOral	Saptalis Pharmaceuticals, LLC.	71656-101	71656-0101-08
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 30 mg/mL	ConcentrateOral	Saptalis Pharmaceuticals, LLC.	71656-102	71656-0102-04
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 25 mg/mL	InjectionIntramuscular	Novadoz Pharmaceuticals LLC	72205-191	72205-0191-25
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 25 mg/mL	InjectionIntramuscular	Novadoz Pharmaceuticals LLC	72205-190	72205-0190-25
Chlorpromazine Hydrochloride	Chlorpromazine hydrochloride 25 mg/1	Tablet, Sugar coatedOral	Coupler LLC	67046-1633	67046-1633-03
chlorpromazine hydrochloride	Chlorpromazine hydrochloride 30 mg/mL	ConcentrateOral	Advagen Pharma Ltd	72888-457	72888-0457-01

All 107 Chlorpromazine hydrochloride NDCs

Other NDCs under ANDA 216911

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

FDA NDC Directory listings under ANDA 216911
Product	Strength	Form · route	Labeler	Product NDC
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride 25 mg/mL	InjectionIntramuscular	Piramal Critical Care Inc.	66794-249
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride 25 mg/mL	InjectionIntramuscular	Piramal Critical Care Inc.	66794-250
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride 25 mg/mL	InjectionIntramuscular	Gland Pharma Limited	68083-533