promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: kesin pharma corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler kesin pharma corporation
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-016
Product ID 81033-016_303b389f-b276-52cb-e063-6294a90a6e2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040891
Listing Expiration 2026-12-31
Marketing Start 2024-12-31

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033016
Hyphenated Format 81033-016

Supplemental Identifiers

RxCUI
992432
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 ANDA040891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 50 CUP, UNIT-DOSE in 1 CARTON (81033-016-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-016-05)
source: ndc

Packages (1)

81033-016-50 50 CUP, UNIT-DOSE in 1 CARTON (81033-016-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-016-05)

Ingredients (1)

promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

PROMETHAZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "303b389f-b276-52cb-e063-6294a90a6e2e", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["28793bd2-bd40-4571-e063-6394a90ae789"], "manufacturer_name": ["Kesin Pharma Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": "50 CUP, UNIT-DOSE in 1 CARTON (81033-016-50)  / 5 mL in 1 CUP, UNIT-DOSE (81033-016-05)", "package_ndc": "81033-016-50", "marketing_start_date": "20241231"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "81033-016_303b389f-b276-52cb-e063-6294a90a6e2e", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "81033-016", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040891", "marketing_category": "ANDA", "marketing_start_date": "20241231", "listing_expiration_date": "20261231"}