phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-808
Product ID 71288-808_80aeb2e2-c42c-454b-a2da-880b0ff9319d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210333
Listing Expiration 2026-12-31
Marketing Start 2018-04-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288808
Hyphenated Format 71288-808

Supplemental Identifiers

RxCUI
1232651
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 ANDA210333 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75)
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-77) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (2)

71288-808-76 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75) 71288-808-77 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-77) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

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": "80aeb2e2-c42c-454b-a2da-880b0ff9319d", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1232651"], "spl_set_id": ["943638b7-527b-4724-a6b7-2018862396d4"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75)", "package_ndc": "71288-808-76", "marketing_start_date": "20180427"}, {"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-77)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "71288-808-77", "marketing_start_date": "20180427"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "71288-808_80aeb2e2-c42c-454b-a2da-880b0ff9319d", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "71288-808", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA210333", "marketing_category": "ANDA", "marketing_start_date": "20180427", "listing_expiration_date": "20261231"}