phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler sola pharmaceuticals, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 100 mg/mL

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-866
Product ID 70512-866_45728b25-194d-ddeb-e063-6294a90af4c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215183
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512866
Hyphenated Format 70512-866

Supplemental Identifiers

RxCUI
1234571 1234579
UPC
0370512865023
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 ANDA215183 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (70512-866-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

70512-866-05 1 BOTTLE, DROPPER in 1 CARTON (70512-866-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

phenylephrine hydrochloride (100 mg/mL)

Linked Drug Pages (1)

Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "45728b25-194d-ddeb-e063-6294a90af4c9", "openfda": {"upc": ["0370512865023"], "unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["bf264b20-6d00-495e-90c7-9172d4535ec7"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70512-866-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "70512-866-05", "marketing_start_date": "20240601"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "70512-866_45728b25-194d-ddeb-e063-6294a90af4c9", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70512-866", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA215183", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}