Biorphen (phenylephrine hydrochloride) NDC 43598-199

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-199Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0199Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43598-199-10	43598019910	10 AMPULE in 1 CARTON (43598-199-10) / 1 mL in 1 AMPULE (43598-199-01)Marketed from Nov 25, 2022

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): Biorphen
Generic name (nonproprietary): phenylephrine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 10 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Dr. Reddy's Laboratories Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212909
Marketing start: Nov 25, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 43598-199_884b0378-92e0-f3ed-176b-ff409f29747fSPL ID 884b0378-92e0-f3ed-176b-ff409f29747fSPL set ID 2f715e4e-b269-b935-d2c9-003cb29770beRxCUI 1666372, 2262018, 2533434, 2533437UNII 04JA59TNSJUPC 0343598172255, 0343598172057
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.

How CPT relates to drug billing

NDC on a medical claim

N443598019910 followed by a unit qualifier and the quantity

Package 43598-0199-10. 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 Mar 31, 2026.

Indications (excerpt from the label)

BIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. BIORPHEN 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 212909

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 212909
Product	Strength	Form · route	Labeler	Product NDC
Biorphenphenylephrine hydrochloride	Phenylephrine hydrochloride .1 mg/mL	Injection, SolutionIntravenous	Dr. Reddy's Laboratories Inc.	43598-172