phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6229
Product ID 0641-6229_031d1d06-e0be-4836-8180-92beded4510c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203826
Listing Expiration 2026-12-31
Marketing Start 2012-12-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416229
Hyphenated Format 0641-6229

Supplemental Identifiers

RxCUI
1666372
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 NDA203826 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6229-25) / 1 mL in 1 VIAL (0641-6229-01)
source: ndc

Packages (1)

0641-6229-25 25 VIAL in 1 CARTON (0641-6229-25) / 1 mL in 1 VIAL (0641-6229-01)

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": "031d1d06-e0be-4836-8180-92beded4510c", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["c3f358dd-4a36-4808-9943-e01f88604be5"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6229-25)  / 1 mL in 1 VIAL (0641-6229-01)", "package_ndc": "0641-6229-25", "marketing_start_date": "20121218"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "0641-6229_031d1d06-e0be-4836-8180-92beded4510c", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0641-6229", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA203826", "marketing_category": "NDA", "marketing_start_date": "20121218", "listing_expiration_date": "20261231"}