promethazine hydrochloride

Generic: promethazine hydrochloride

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

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 50 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-522
Product ID 65162-522_ce7bb9fa-e802-467c-b3e3-46f92abcdce8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091179
Listing Expiration 2026-12-31
Marketing Start 2011-03-03

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162522
Hyphenated Format 65162-522

Supplemental Identifiers

RxCUI
992438 992447 992475
UPC
0365162522105 0365162521108 0365162745108
UNII
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 (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA091179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65162-522-10)
  • 500 TABLET in 1 BOTTLE (65162-522-50)
source: ndc

Packages (2)

65162-522-10 100 TABLET in 1 BOTTLE (65162-522-10) 65162-522-50 500 TABLET in 1 BOTTLE (65162-522-50)

Ingredients (1)

promethazine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ce7bb9fa-e802-467c-b3e3-46f92abcdce8", "openfda": {"upc": ["0365162522105", "0365162521108", "0365162745108"], "unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["05907a49-537f-4bf2-8a5f-5e905f19fece"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-522-10)", "package_ndc": "65162-522-10", "marketing_start_date": "20110303"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-522-50)", "package_ndc": "65162-522-50", "marketing_start_date": "20110303"}], "brand_name": "Promethazine Hydrochloride", "product_id": "65162-522_ce7bb9fa-e802-467c-b3e3-46f92abcdce8", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "65162-522", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA091179", "marketing_category": "ANDA", "marketing_start_date": "20110303", "listing_expiration_date": "20261231"}