Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 0781-9227
Phenylephrine hydrochloride 10 mg/mL · Injection · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-9227-95 | 00781922795 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-9227-95) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0781-9227-75)Marketed from Feb 17, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208905
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 0781-9227_eb4076c0-0b18-332f-e053-2a95a90aae13SPL ID eb4076c0-0b18-332f-e053-2a95a90aae13SPL set ID 5788f8c6-f868-4b83-81dc-dc485d8716c0RxCUI 1232651, 1666372UNII 04JA59TNSJ
- Pharmacologic class
- alpha-1 Adrenergic Agonist
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
N400781922795followed by a unit qualifier and the quantityPackage 00781-9227-95. 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 .
Indications (excerpt from the label)
Phenylephrine hydrochloride injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208905
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 |
|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-3422 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-9226 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-9228 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-3458 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Sandoz Inc | 0781-3466 |