Prescription drug · NDA
Phenylephrine Hydrochloride NDC 0641-6188
Phenylephrine hydrochloride 10 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6188-10 | 00641618810 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0641-6188-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6188-01)Marketed from Jun 19, 2019 |
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
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203826
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 0641-6188_a3fa3e8a-c234-464e-99ef-c187f2e7d315SPL ID a3fa3e8a-c234-464e-99ef-c187f2e7d315SPL set ID e1a7ab4b-0afe-4463-a039-5be0323cf2f7RxCUI 1232651, 1666372, 2262018, 2634228, 2634233, 2634235UNII 04JA59TNSJUPC 0306416188104
- 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
N400641618810followed by a unit qualifier and the quantityPackage 00641-6188-10. 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)
IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/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. IMMPHENTIV injection 100 mcg/mL is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is alpha…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203826
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 | 71872-7043 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6189 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6229 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6142 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-571 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-570 |
| Immphentivphenylephrine hydrochloride | Phenylephrine hydrochloride 100 ug/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6245 |
| Immphentivphenylephrine hydrochloride | Phenylephrine hydrochloride 100 ug/mL | Injectable, LiposomalIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6246 |
| Phenylephrine Hci | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1249 |