phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-315
Product ID 25021-315_045c8994-a54f-4b5c-8b70-7cf7c962a59f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209967
Listing Expiration 2026-12-31
Marketing Start 2020-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021315
Hyphenated Format 25021-315

Supplemental Identifiers

RxCUI
1232651 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 ANDA209967 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (25021-315-01) / 1 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-315-98) / 10 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-315-99) / 5 mL in 1 VIAL
source: ndc

Packages (3)

25021-315-01 25 VIAL in 1 CARTON (25021-315-01) / 1 mL in 1 VIAL 25021-315-98 1 VIAL in 1 CARTON (25021-315-98) / 10 mL in 1 VIAL 25021-315-99 10 VIAL in 1 CARTON (25021-315-99) / 5 mL in 1 VIAL

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": "045c8994-a54f-4b5c-8b70-7cf7c962a59f", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["b3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (25021-315-01)  / 1 mL in 1 VIAL", "package_ndc": "25021-315-01", "marketing_start_date": "20201015"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-315-98)  / 10 mL in 1 VIAL", "package_ndc": "25021-315-98", "marketing_start_date": "20201015"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-315-99)  / 5 mL in 1 VIAL", "package_ndc": "25021-315-99", "marketing_start_date": "20201015"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "25021-315_045c8994-a54f-4b5c-8b70-7cf7c962a59f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "25021-315", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA209967", "marketing_category": "ANDA", "marketing_start_date": "20201015", "listing_expiration_date": "20261231"}