promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-140
Product ID 51655-140_48c3d54f-f13b-5a44-e063-6394a90aa096
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083426
Listing Expiration 2027-12-31
Marketing Start 2023-02-03

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655140
Hyphenated Format 51655-140

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 ANDA083426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (51655-140-52)
  • 10 TABLET in 1 BOTTLE, PLASTIC (51655-140-53)
source: ndc

Packages (2)

51655-140-52 30 TABLET in 1 BOTTLE, PLASTIC (51655-140-52) 51655-140-53 10 TABLET in 1 BOTTLE, PLASTIC (51655-140-53)

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": "48c3d54f-f13b-5a44-e063-6394a90aa096", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["f6ca1097-1c75-c682-e053-6294a90a2bd6"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (51655-140-52)", "package_ndc": "51655-140-52", "marketing_start_date": "20230203"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (51655-140-53)", "package_ndc": "51655-140-53", "marketing_start_date": "20230203"}], "brand_name": "Promethazine Hydrochloride", "product_id": "51655-140_48c3d54f-f13b-5a44-e063-6394a90aa096", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "51655-140", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA083426", "marketing_category": "ANDA", "marketing_start_date": "20230203", "listing_expiration_date": "20271231"}