promethazine and phenylephrine hcl, and codeine phosphate

Generic: promethazine, phenylephrine, codeine

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

Drug Facts

Product Profile

Brand Name promethazine and phenylephrine hcl, and codeine phosphate
Generic Name promethazine, phenylephrine, codeine
Labeler amneal pharmaceuticals llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

codeine phosphate 10 mg/5mL, phenylephrine hydrochloride 5 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-694
Product ID 65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200963
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2013-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162694
Hyphenated Format 65162-694

Supplemental Identifiers

RxCUI
996757
UNII
GSL05Y1MN6 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 and phenylephrine hcl, and codeine phosphate (source: ndc)
Generic Name promethazine, phenylephrine, codeine (source: ndc)
Application Number ANDA200963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 5 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (65162-694-86)
  • 473 mL in 1 BOTTLE (65162-694-90)
source: ndc

Packages (2)

65162-694-86 118 mL in 1 BOTTLE (65162-694-86) 65162-694-90 473 mL in 1 BOTTLE (65162-694-90)

Ingredients (3)

codeine phosphate (10 mg/5mL) phenylephrine hydrochloride (5 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine and Phenylephrine HCl, and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fa597180-cb04-48de-ba6c-1cc3781d7f31", "openfda": {"unii": ["GSL05Y1MN6", "04JA59TNSJ", "R61ZEH7I1I"], "rxcui": ["996757"], "spl_set_id": ["5f23b254-872b-4e88-91be-710c3ea7687b"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (65162-694-86)", "package_ndc": "65162-694-86", "marketing_start_date": "20131101"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-694-90)", "package_ndc": "65162-694-90", "marketing_start_date": "20131101"}], "brand_name": "Promethazine and Phenylephrine HCl, and Codeine Phosphate", "product_id": "65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65162-694", "dea_schedule": "CV", "generic_name": "Promethazine, Phenylephrine, Codeine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine and Phenylephrine HCl, and Codeine Phosphate", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA200963", "marketing_category": "ANDA", "marketing_start_date": "20131101", "listing_expiration_date": "20271231"}