What is NDC 68083-435?

68083-435 is the product NDC for Prochlorperazine Edisylate, Prochlorperazine edisylate 5 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 Prochlorperazine Edisylate?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prochlorperazine Edisylate NDC 68083-435

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0435Add 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
68083-435-10	6808304351068083043510	10 VIAL in 1 CARTON (68083-435-10) / 2 mL in 1 VIAL (68083-435-01)Marketed from Sep 22, 2021
68083-435-25	6808304352568083043525	25 VIAL in 1 CARTON (68083-435-25) / 2 mL in 1 VIAL (68083-435-01)Marketed from Sep 22, 2021

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): Prochlorperazine Edisylate
Generic name (nonproprietary): prochlorperazine edisylate
Active ingredients: Prochlorperazine edisylate — 5 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214107
Marketing start: Sep 22, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 68083-435_868ffb82-fd9b-4157-9e2c-1b76191ac1aaSPL ID 868ffb82-fd9b-4157-9e2c-1b76191ac1aaSPL set ID a0fd3d58-7470-4d0f-9e6c-84e92c02a97fRxCUI 2102949UNII PG20W5VQZSUPC 0368083436018, 0368083435103, 0368083435257
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

N468083043510 followed by a unit qualifier and the quantity

Package 68083-0435-10. 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 Dec 12, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-435

What is NDC 68083-435?: 68083-435 is the product NDC for Prochlorperazine Edisylate, Prochlorperazine edisylate 5 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?: Prochlorperazine Edisylate.
What is the active ingredient?: Prochlorperazine edisylate.
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 Prochlorperazine Edisylate?: 17 other product NDCs are listed under this name. See all Prochlorperazine Edisylate 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 Prochlorperazine Edisylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Caplin Steriles Limited	65145-119	65145-0119-10
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Somerset Therapeutics, LLC	70069-371	70069-0371-25
prochlorperazine edisylate	Prochlorperazine edisylate 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Avenacy Inc.	83634-778	83634-0778-02
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	FOSUN PHARMA USA INC	72266-204	72266-0204-10
prochlorperazine edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Amneal Pharmaceuticals LLC	70121-1580	70121-1580-0570121-1580-07
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Eugia US LLC	55150-360	55150-0360-0155150-0360-25
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1558	51662-1558-03
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Cosette Pharmaceuticals, Inc.	0713-0351	00713-0351-0900713-0351-25
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-790	25021-0790-0225021-0790-03
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-436	68083-0436-01

All 18 Prochlorperazine Edisylate NDCs

Other NDCs under ANDA 214107

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

FDA NDC Directory listings under ANDA 214107
Product	Strength	Form · route	Labeler	Product NDC
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-790
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	Gland Pharma Limited	68083-436
Prochlorperazine Edisylate	Prochlorperazine edisylate 5 mg/mL	InjectionIntramuscular, Intravenous	FOSUN PHARMA USA INC	72266-204