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 72162-2071
Product ID 72162-2071_f04e3aa5-37d8-4ba8-919f-9c61255b5bc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213890
Listing Expiration 2026-12-31
Marketing Start 2021-07-12

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622071
Hyphenated Format 72162-2071

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 ANDA213890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (72162-2071-2)
source: ndc

Packages (1)

72162-2071-2 473 mL in 1 BOTTLE (72162-2071-2)

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": "f04e3aa5-37d8-4ba8-919f-9c61255b5bc4", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["07914b6e-c40f-44be-a1db-8724c70f99b6"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (72162-2071-2)", "package_ndc": "72162-2071-2", "marketing_start_date": "20230815"}], "brand_name": "Promethazine Hydrochloride", "product_id": "72162-2071_f04e3aa5-37d8-4ba8-919f-9c61255b5bc4", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "72162-2071", "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": "ANDA213890", "marketing_category": "ANDA", "marketing_start_date": "20210712", "listing_expiration_date": "20261231"}