Prescription drug · ANDA
Phenylephrine hydrochloride NDC 84549-621
Phenylephrine hydrochloride 10 mg/mL · Injection · Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-621-25 | 84549062125 | 1 mL in 1 VIAL (84549-621-25)Marketed from Aug 27, 2025 |
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
- Labeler
- ProPharma DistributionNDC labeler code 84549
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217069
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 84549-621_463d1c23-2403-026d-e063-6394a90a3bf4SPL ID 463d1c23-2403-026d-e063-6394a90a3bf4SPL set ID 386663e8-f1f6-cf14-e063-6394a90a68dfRxCUI 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
N484549062125followed by a unit qualifier and the quantityPackage 84549-0621-25. 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 .
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.
About NDC 84549-621
- What is NDC 84549-621?
- 84549-621 is the product NDC for Phenylephrine hydrochloride, Phenylephrine hydrochloride 10 mg/mL injection, listed with the FDA by ProPharma Distribution. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenylephrine hydrochloride.
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- ProPharma Distribution, NDC labeler code 84549. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenylephrine hydrochloride?
- 107 other product NDCs are listed under this name. See all Phenylephrine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenylephrine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-168 | 81469-0168-0281469-0168-15 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-169 | 81469-0169-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-388 | 65219-0388-01 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-115 | 65145-0115-25 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 50 mg/5mL | InjectionIntravenous | Caplin Steriles Limited | 65145-116 | 65145-0116-0165145-0116-10 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/10mL | InjectionIntravenous | Caplin Steriles Limited | 65145-117 | 65145-0117-01 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-358 | 36000-0358-25 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-360 | 36000-0360-10 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-362 | 36000-0362-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Method Pharmaceuticals, LLC | 58657-851 | 58657-0851-26 |
Other NDCs under ANDA 217069
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 | Lifestar Pharma LLC | 70756-621 |
| Phenylephrine hydrochloride | Phenylephrine hydrochloride 50 mg/5mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-622 |
| Phenylephrine hydrochloride | Phenylephrine hydrochloride 100 mg/10mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-623 |