promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-162
Product ID 68001-162_3d817fa0-d0c1-9b87-e063-6394a90af502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2014-01-13

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001162
Hyphenated Format 68001-162

Supplemental Identifiers

RxCUI
992438 992447 992475
UPC
0368001161008 0368001162005 0368001163002
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 ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68001-162-00)
  • 500 TABLET in 1 BOTTLE (68001-162-03)
source: ndc

Packages (2)

68001-162-00 100 TABLET in 1 BOTTLE (68001-162-00) 68001-162-03 500 TABLET in 1 BOTTLE (68001-162-03)

Ingredients (1)

promethazine hydrochloride (25 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": "3d817fa0-d0c1-9b87-e063-6394a90af502", "openfda": {"upc": ["0368001161008", "0368001162005", "0368001163002"], "unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["44cd6d46-fbb9-4836-9426-d8ce2cb6d66d"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68001-162-00)", "package_ndc": "68001-162-00", "marketing_start_date": "20140113"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68001-162-03)", "package_ndc": "68001-162-03", "marketing_start_date": "20230727"}], "brand_name": "Promethazine Hydrochloride", "product_id": "68001-162_3d817fa0-d0c1-9b87-e063-6394a90af502", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68001-162", "generic_name": "Promethazine Hydrochloride", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20140113", "listing_expiration_date": "20261231"}