phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Provepharm Inc.

Identifiers & Regulatory

Product NDC 81284-211
Product ID 81284-211_9302b62e-3f80-4e5c-afa5-a775ed2c2ebe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211081
Listing Expiration 2026-12-31
Marketing Start 2020-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81284211
Hyphenated Format 81284-211

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0381284212106 0381284213011
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 ANDA211081 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (81284-211-25) / 1 mL in 1 VIAL (81284-211-00)
source: ndc

Packages (1)

81284-211-25 25 VIAL in 1 CARTON (81284-211-25) / 1 mL in 1 VIAL (81284-211-00)

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": "9302b62e-3f80-4e5c-afa5-a775ed2c2ebe", "openfda": {"upc": ["0381284212106", "0381284213011"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["e1d3881f-fa9e-4d68-8ef0-9e03435fc292"], "manufacturer_name": ["Provepharm Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (81284-211-25)  / 1 mL in 1 VIAL (81284-211-00)", "package_ndc": "81284-211-25", "marketing_start_date": "20200812"}], "brand_name": "Phenylephrine hydrochloride", "product_id": "81284-211_9302b62e-3f80-4e5c-afa5-a775ed2c2ebe", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "81284-211", "generic_name": "Phenylephrine hydrochloride", "labeler_name": "Provepharm Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA211081", "marketing_category": "ANDA", "marketing_start_date": "20200812", "listing_expiration_date": "20261231"}