promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2377
Product ID 72162-2377_30e03661-9498-4ac2-a59c-a0dd99d387ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040891
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622377
Hyphenated Format 72162-2377

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
  • 473 mL in 1 BOTTLE (72162-2377-2)
source: ndc

Packages (1)

72162-2377-2 473 mL in 1 BOTTLE (72162-2377-2)

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": "30e03661-9498-4ac2-a59c-a0dd99d387ff", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["a4b3da5b-1129-43c2-bf22-3a29c3fae116"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (72162-2377-2)", "package_ndc": "72162-2377-2", "marketing_start_date": "20240730"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "72162-2377_30e03661-9498-4ac2-a59c-a0dd99d387ff", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "72162-2377", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "Bryant Ranch Prepack", "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": "20240220", "listing_expiration_date": "20261231"}