phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: hainan poly pharm. co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler hainan poly pharm. co., ltd.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Hainan Poly Pharm. Co., Ltd.

Identifiers & Regulatory

Product NDC 14335-441
Product ID 14335-441_13fdb0eb-d8cb-ffd6-e063-6394a90a45ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218412
Listing Expiration 2026-12-31
Marketing Start 2024-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14335441
Hyphenated Format 14335-441

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0314335442108 0314335441019 0314335440012 0314335442016
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 ANDA218412 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

14335-441-01 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE

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": "13fdb0eb-d8cb-ffd6-e063-6394a90a45ba", "openfda": {"upc": ["0314335442108", "0314335441019", "0314335440012", "0314335442016"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["8d6973c4-4a69-4d49-9da7-d2a00df83ecb"], "manufacturer_name": ["Hainan Poly Pharm. Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "14335-441-01", "marketing_start_date": "20240319"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "14335-441_13fdb0eb-d8cb-ffd6-e063-6394a90a45ba", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "14335-441", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Hainan Poly Pharm. Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA218412", "marketing_category": "ANDA", "marketing_start_date": "20240319", "listing_expiration_date": "20261231"}