promethazine hydrochloride and phenylephrine hydrochloride

Generic: promethazine hydrochloride and phenylephrine hydrochloride

Labeler: genus lifesciences inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and phenylephrine hydrochloride
Generic Name promethazine hydrochloride and phenylephrine hydrochloride
Labeler genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

phenylephrine hydrochloride 5 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-345
Product ID 64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040654
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950345
Hyphenated Format 64950-345

Supplemental Identifiers

RxCUI
1248057
UNII
04JA59TNSJ R61ZEH7I1I

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 promethazine hydrochloride and phenylephrine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride and phenylephrine hydrochloride (source: ndc)
Application Number ANDA040654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (64950-345-16)
source: ndc

Packages (1)

64950-345-16 473 mL in 1 BOTTLE, PLASTIC (64950-345-16)

Ingredients (2)

phenylephrine hydrochloride (5 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df5aecd4-2175-4495-b6cc-13d69e718d09", "openfda": {"unii": ["04JA59TNSJ", "R61ZEH7I1I"], "rxcui": ["1248057"], "spl_set_id": ["7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (64950-345-16)", "package_ndc": "64950-345-16", "marketing_start_date": "20240715"}], "brand_name": "Promethazine Hydrochloride and Phenylephrine Hydrochloride", "product_id": "64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Phenothiazine [EPC]", "Phenothiazines [CS]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "64950-345", "generic_name": "promethazine hydrochloride and phenylephrine hydrochloride", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040654", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}