Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 71288-807
Phenylephrine hydrochloride 10 mg/mL · Injection · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-807-02 | 71288080702 | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-807-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-807-01)Marketed from Apr 27, 2018 |
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)
- Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210334
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 71288-807_8c63c2aa-de67-4214-99bc-ba483b08d2b5SPL ID 8c63c2aa-de67-4214-99bc-ba483b08d2b5SPL set ID f2096e12-cbeb-4084-9132-17c7ef46b7b9RxCUI 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
N471288080702followed by a unit qualifier and the quantityPackage 71288-0807-02. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Phenylephrine Hydrochloride Injection 10 mg per mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. Phenylephrine Hydrochloride Injection 10 mg per mL is alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210334
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 | Medical Purchasing Solutions, LLC | 71872-7343 |