Prescription drug · ANDA
Prochlorperazine Edisylate NDC 68083-436
Prochlorperazine edisylate 5 mg/mL · Injection · Intramuscular, Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-436-01 | 68083043601 | 1 VIAL in 1 CARTON (68083-436-01) / 10 mL in 1 VIALMarketed 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 Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214107
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 68083-436_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.
- NDC on a medical claim
N468083043601followed by a unit qualifier and the quantityPackage 68083-0436-01. 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 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.
Other NDCs under ANDA 214107
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | Gland Pharma Limited | 68083-435 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-790 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | FOSUN PHARMA USA INC | 72266-204 |