phenylephrine hydrochloride phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-465
Product ID 68083-465_61b63c37-7fc9-4557-acf6-eea73b84b4c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211920
Listing Expiration 2026-12-31
Marketing Start 2021-04-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083465
Hyphenated Format 68083-465

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0368083338015 0368083339012
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 phenylephrine hydrochloride (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number ANDA211920 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-465-25) / 1 mL in 1 VIAL (68083-465-01)
source: ndc

Packages (1)

68083-465-25 25 VIAL in 1 CARTON (68083-465-25) / 1 mL in 1 VIAL (68083-465-01)

Ingredients (1)

phenylephrine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

phenylephrine hydrochloride, Phenylephrine Hydrochloride Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "61b63c37-7fc9-4557-acf6-eea73b84b4c3", "openfda": {"upc": ["0368083338015", "0368083339012"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["6486d284-5189-4000-aa7d-67150e84a7b2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-465-25)  / 1 mL in 1 VIAL (68083-465-01)", "package_ndc": "68083-465-25", "marketing_start_date": "20210414"}], "brand_name": "Phenylephrine Hydrochloride Phenylephrine Hydrochloride", "product_id": "68083-465_61b63c37-7fc9-4557-acf6-eea73b84b4c3", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "68083-465", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "brand_name_suffix": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA211920", "marketing_category": "ANDA", "marketing_start_date": "20210414", "listing_expiration_date": "20261231"}