phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3422
Product ID 0781-3422_14eec16d-4652-44a3-8cd3-a37b4280deb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208905
Listing Expiration 2026-12-31
Marketing Start 2019-09-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813422
Hyphenated Format 0781-3422

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 ANDA208905 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3422-92) / 1 mL in 1 VIAL, SINGLE-DOSE (0781-3422-71)
source: ndc

Packages (1)

0781-3422-92 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3422-92) / 1 mL in 1 VIAL, SINGLE-DOSE (0781-3422-71)

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": "14eec16d-4652-44a3-8cd3-a37b4280deb8", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["6feb2da2-05ef-47bb-9d8d-01b81ad69059"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3422-92)  / 1 mL in 1 VIAL, SINGLE-DOSE (0781-3422-71)", "package_ndc": "0781-3422-92", "marketing_start_date": "20191216"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "0781-3422_14eec16d-4652-44a3-8cd3-a37b4280deb8", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0781-3422", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA208905", "marketing_category": "ANDA", "marketing_start_date": "20190905", "listing_expiration_date": "20261231"}