phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: be pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler be pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
BE Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71839-127
Product ID 71839-127_fb069778-d16e-40f9-9c02-5496adfcb5d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217521
Listing Expiration 2026-12-31
Marketing Start 2023-07-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71839127
Hyphenated Format 71839-127

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0371839129010 0371839127016 0371839128013
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 phenylephrine hydrochloride (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number ANDA217521 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-127-01)
source: ndc

Packages (1)

71839-127-25 25 VIAL, SINGLE-DOSE in 1 CARTON (71839-127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-127-01)

Ingredients (1)

phenylephrine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fb069778-d16e-40f9-9c02-5496adfcb5d2", "openfda": {"upc": ["0371839129010", "0371839127016", "0371839128013"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["fb069778-d16e-40f9-9c02-5496adfcb5d2"], "manufacturer_name": ["BE Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (71839-127-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (71839-127-01)", "package_ndc": "71839-127-25", "marketing_start_date": "20230710"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "71839-127_fb069778-d16e-40f9-9c02-5496adfcb5d2", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "71839-127", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "BE Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA217521", "marketing_category": "ANDA", "marketing_start_date": "20230710", "listing_expiration_date": "20261231"}