biorphen

Generic: phenylephrine hydrochloride

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name biorphen
Generic Name phenylephrine hydrochloride
Labeler dr. reddy's laboratories inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride .1 mg/mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-172
Product ID 43598-172_104a61eb-0a80-164a-2d4a-eaf4ef9b9316
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212909
Listing Expiration 2026-12-31
Marketing Start 2022-11-25

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598172
Hyphenated Format 43598-172

Supplemental Identifiers

RxCUI
1666372 2262018 2533434 2533437
UPC
0343598172057 0343598172255
UNII
04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name biorphen (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number NDA212909 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05)
  • 5 mL in 1 VIAL (43598-172-25)
source: ndc

Packages (2)

43598-172-15 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) 43598-172-25 5 mL in 1 VIAL (43598-172-25)

Ingredients (1)

phenylephrine hydrochloride (.1 mg/mL)

Linked Drug Pages (1)

Biorphen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "104a61eb-0a80-164a-2d4a-eaf4ef9b9316", "openfda": {"upc": ["0343598172057", "0343598172255"], "unii": ["04JA59TNSJ"], "rxcui": ["1666372", "2262018", "2533434", "2533437"], "spl_set_id": ["2f715e4e-b269-b935-d2c9-003cb29770be"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (43598-172-15)  / 5 mL in 1 AMPULE (43598-172-05)", "package_ndc": "43598-172-15", "marketing_start_date": "20221125"}, {"sample": false, "description": "5 mL in 1 VIAL (43598-172-25)", "package_ndc": "43598-172-25", "marketing_start_date": "20240510"}], "brand_name": "Biorphen", "product_id": "43598-172_104a61eb-0a80-164a-2d4a-eaf4ef9b9316", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "43598-172", "generic_name": "Phenylephrine hydrochloride", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Biorphen", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": ".1 mg/mL"}], "application_number": "NDA212909", "marketing_category": "NDA", "marketing_start_date": "20221125", "listing_expiration_date": "20261231"}