promethazine hydrochloride and phenylephrine hydrochloride

Generic: promethazine and phenylephrine

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

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and phenylephrine hydrochloride
Generic Name promethazine and phenylephrine
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-679
Product ID 65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040902
Listing Expiration 2026-12-31
Marketing Start 2009-08-25

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 65162679
Hyphenated Format 65162-679

Supplemental Identifiers

RxCUI
1248057
UPC
0365162679861 0365162679908
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 and phenylephrine (source: ndc)
Application Number ANDA040902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (65162-679-86)
  • 473 mL in 1 BOTTLE (65162-679-90)
source: ndc

Packages (2)

65162-679-86 118 mL in 1 BOTTLE (65162-679-86) 65162-679-90 473 mL in 1 BOTTLE (65162-679-90)

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": "1cd384c6-b844-40d6-84bf-cdea9bbd334a", "openfda": {"upc": ["0365162679861", "0365162679908"], "unii": ["04JA59TNSJ", "R61ZEH7I1I"], "rxcui": ["1248057"], "spl_set_id": ["cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (65162-679-86)", "package_ndc": "65162-679-86", "marketing_start_date": "20090825"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-679-90)", "package_ndc": "65162-679-90", "marketing_start_date": "20090825"}], "brand_name": "Promethazine Hydrochloride and Phenylephrine Hydrochloride", "product_id": "65162-679_1cd384c6-b844-40d6-84bf-cdea9bbd334a", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Phenothiazine [EPC]", "Phenothiazines [CS]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65162-679", "generic_name": "Promethazine and Phenylephrine", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "ANDA040902", "marketing_category": "ANDA", "marketing_start_date": "20090825", "listing_expiration_date": "20261231"}