promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7886
Product ID 68788-7886_5c684bfa-9a87-4298-a8f3-407c841a764f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2021-04-16

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887886
Hyphenated Format 68788-7886

Supplemental Identifiers

RxCUI
992447
UNII
R61ZEH7I1I

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
  • 10 TABLET in 1 BOTTLE (68788-7886-1)
  • 20 TABLET in 1 BOTTLE (68788-7886-2)
  • 30 TABLET in 1 BOTTLE (68788-7886-3)
  • 12 TABLET in 1 BOTTLE (68788-7886-8)
source: ndc

Packages (4)

68788-7886-1 10 TABLET in 1 BOTTLE (68788-7886-1) 68788-7886-2 20 TABLET in 1 BOTTLE (68788-7886-2) 68788-7886-3 30 TABLET in 1 BOTTLE (68788-7886-3) 68788-7886-8 12 TABLET in 1 BOTTLE (68788-7886-8)

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": "5c684bfa-9a87-4298-a8f3-407c841a764f", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["974208c8-4aad-4fb9-991b-cf3085034272"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68788-7886-1)", "package_ndc": "68788-7886-1", "marketing_start_date": "20210416"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-7886-2)", "package_ndc": "68788-7886-2", "marketing_start_date": "20210416"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-7886-3)", "package_ndc": "68788-7886-3", "marketing_start_date": "20210416"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (68788-7886-8)", "package_ndc": "68788-7886-8", "marketing_start_date": "20210416"}], "brand_name": "Promethazine Hydrochloride", "product_id": "68788-7886_5c684bfa-9a87-4298-a8f3-407c841a764f", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68788-7886", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20210416", "listing_expiration_date": "20261231"}