Prescription drug · ANDA
prochlorperazine edisylate NDC 83634-778
Prochlorperazine edisylate 5 mg/mL · Injection, Solution · Intramuscular, Intravenous · Avenacy Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-778-02 | 8363407780283634077802 | 10 VIAL in 1 CARTON (83634-778-02) / 2 mL in 1 VIAL (83634-778-41)Marketed from Jun 1, 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)
- prochlorperazine edisylate
- Generic name (nonproprietary)
- prochlorperazine edisylate
- Active ingredients
- Prochlorperazine edisylate — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Avenacy Inc.NDC labeler code 83634
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204147
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)
- Identifiers
- Product ID 83634-778_d8b06d8a-15cf-4aaa-933b-76bf2b4b035aSPL ID d8b06d8a-15cf-4aaa-933b-76bf2b4b035aSPL set ID fd07a1a3-c0df-4926-9964-07348e45a5fdRxCUI 2102949UNII 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
N483634077802followed by a unit qualifier and the quantityPackage 83634-0778-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 83634-778
- What is NDC 83634-778?
- 83634-778 is the product NDC for prochlorperazine edisylate, Prochlorperazine edisylate 5 mg/mL injection, solution, listed with the FDA by Avenacy 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?
- Avenacy Inc., NDC labeler code 83634. 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 | 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 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | Gland Pharma Limited | 68083-436 | 68083-0436-01 |
Other NDCs under ANDA 204147
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-294 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-523 |
| Prochlorperazine Edisylate | Prochlorperazine edisylate 5 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-4183 |