Prescription drug · ANDA
Prochlorperazine Edisylate NDC 72572-580
Prochlorperazine edisylate 5 mg/mL · Injection · Intramuscular, Intravenous · Civica, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72572-580-25 | 7257205802572572058025 | 25 VIAL in 1 CARTON (72572-580-25) / 2 mL in 1 VIAL (72572-580-01)Marketed from Nov 18, 2019 |
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
- Civica, Inc.NDC labeler code 72572
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089903
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 72572-580_7395a535-b3fc-4bb8-b2e1-d8c42b9a0509SPL ID 7395a535-b3fc-4bb8-b2e1-d8c42b9a0509SPL set ID e3e0c6c5-6b92-40e0-a926-29c64846be93RxCUI 314192UNII PG20W5VQZS
- 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
N472572058025followed by a unit qualifier and the quantityPackage 72572-0580-25. 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 . 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.
About NDC 72572-580
- What is NDC 72572-580?
- 72572-580 is the product NDC for Prochlorperazine Edisylate, Prochlorperazine edisylate 5 mg/mL injection, listed with the FDA by Civica, Inc.. It has 1 package NDC, 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?
- Civica, Inc., NDC labeler code 72572. 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.
Related NDCs: other Prochlorperazine Edisylate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 68083-435 | 68083-0435-1068083-0435-25 |
Other NDCs under ANDA 089903
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 | Hikma Pharmaceuticals USA Inc. | 0641-6135 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1558 |