phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9931
Product ID 0404-9931_a4ecb606-abf4-4f16-9c91-13d33831033c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211079
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049931
Hyphenated Format 0404-9931

Supplemental Identifiers

RxCUI
1666372
UNII
04JA59TNSJ

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 ANDA211079 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9931-99 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "a4ecb606-abf4-4f16-9c91-13d33831033c", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["db313f72-a6bb-444f-949f-19b4aa6f61c0"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9931-99", "marketing_start_date": "20220113"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "0404-9931_a4ecb606-abf4-4f16-9c91-13d33831033c", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0404-9931", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA211079", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}