phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-115
Product ID 65145-115_bce68fbe-1f6e-4648-a3f9-3fc6ece5cb23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213318
Listing Expiration 2026-12-31
Marketing Start 2020-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145115
Hyphenated Format 65145-115

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0365145117014 0365145115010 0365145116017 0365145113016
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 ANDA213318 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (65145-115-25) / 1 mL in 1 VIAL (65145-115-01)
source: ndc

Packages (1)

65145-115-25 25 VIAL in 1 CARTON (65145-115-25) / 1 mL in 1 VIAL (65145-115-01)

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": "bce68fbe-1f6e-4648-a3f9-3fc6ece5cb23", "openfda": {"upc": ["0365145117014", "0365145115010", "0365145116017", "0365145113016"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["1b9f1d54-ea46-49c8-a33e-c94a61bc0460"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (65145-115-25)  / 1 mL in 1 VIAL (65145-115-01)", "package_ndc": "65145-115-25", "marketing_start_date": "20200630"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "65145-115_bce68fbe-1f6e-4648-a3f9-3fc6ece5cb23", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65145-115", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA213318", "marketing_category": "ANDA", "marketing_start_date": "20200630", "listing_expiration_date": "20261231"}