promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler asclemed usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 87063-014
Product ID 87063-014_41a47d00-8acc-6eba-e063-6294a90ae752
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2005-12-14

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87063014
Hyphenated Format 87063-014

Supplemental Identifiers

RxCUI
992438 992447 992475
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
  • 12.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (87063-014-00)
  • 100 TABLET in 1 BOTTLE (87063-014-01)
  • 500 TABLET in 1 BOTTLE (87063-014-05)
  • 10 TABLET in 1 BOTTLE (87063-014-10)
  • 20 TABLET in 1 BOTTLE (87063-014-20)
  • 30 TABLET in 1 BOTTLE (87063-014-30)
  • 60 TABLET in 1 BOTTLE (87063-014-60)
  • 90 TABLET in 1 BOTTLE (87063-014-90)
source: ndc

Packages (8)

87063-014-00 1000 TABLET in 1 BOTTLE (87063-014-00) 87063-014-01 100 TABLET in 1 BOTTLE (87063-014-01) 87063-014-05 500 TABLET in 1 BOTTLE (87063-014-05) 87063-014-10 10 TABLET in 1 BOTTLE (87063-014-10) 87063-014-20 20 TABLET in 1 BOTTLE (87063-014-20) 87063-014-30 30 TABLET in 1 BOTTLE (87063-014-30) 87063-014-60 60 TABLET in 1 BOTTLE (87063-014-60) 87063-014-90 90 TABLET in 1 BOTTLE (87063-014-90)

Ingredients (1)

promethazine hydrochloride (12.5 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": "41a47d00-8acc-6eba-e063-6294a90ae752", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["4d30e587-6d59-4cf5-ab45-c7639f759df9"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (87063-014-00)", "package_ndc": "87063-014-00", "marketing_start_date": "20251017"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (87063-014-01)", "package_ndc": "87063-014-01", "marketing_start_date": "20251017"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (87063-014-05)", "package_ndc": "87063-014-05", "marketing_start_date": "20251017"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (87063-014-10)", "package_ndc": "87063-014-10", "marketing_start_date": "20251017"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (87063-014-20)", "package_ndc": "87063-014-20", "marketing_start_date": "20251017"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (87063-014-30)", "package_ndc": "87063-014-30", "marketing_start_date": "20251017"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (87063-014-60)", "package_ndc": "87063-014-60", "marketing_start_date": "20251017"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (87063-014-90)", "package_ndc": "87063-014-90", "marketing_start_date": "20251017"}], "brand_name": "Promethazine Hydrochloride", "product_id": "87063-014_41a47d00-8acc-6eba-e063-6294a90ae752", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "87063-014", "generic_name": "Promethazine Hydrochloride", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20051214", "listing_expiration_date": "20261231"}