Prescription drug · NDA
Biorphen (Phenylephrine hydrochloride) NDC 43598-172
Phenylephrine hydrochloride .1 mg/mL · Injection, Solution · Intravenous · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-172-15 | 4359801721543598017215 | 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05)Marketed from Nov 25, 2022 | |
| 43598-172-25 | 4359801722543598017225 | 5 mL in 1 VIAL (43598-172-25)Marketed from May 10, 2024 |
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 — .1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212909
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 43598-172_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.
- NDC on a medical claim
N443598017215followed by a unit qualifier and the quantityPackage 43598-0172-15. 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)
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.
About NDC 43598-172
- What is NDC 43598-172?
- 43598-172 is the product NDC for Biorphen (phenylephrine hydrochloride), Phenylephrine hydrochloride .1 mg/mL injection, solution, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Biorphen (Phenylephrine hydrochloride).
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Biorphen?
- 1 other product NDC are listed under this name. See all Biorphen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Biorphen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Biorphenphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-199 | 43598-0199-10 |
Other NDCs under NDA 212909
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 |
|---|---|---|---|---|
| Biorphenphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Laboratories Inc. | 43598-199 |