promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

promethazine hydrochloride 50 mg/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-5550
Product ID 39822-5550_0e860109-725f-1c28-e063-6394a90a50ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040737
Listing Expiration 2026-12-31
Marketing Start 2015-01-30

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398225550
Hyphenated Format 39822-5550

Supplemental Identifiers

RxCUI
992858
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 ANDA040737 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 AMPULE in 1 CARTON (39822-5550-6) / 1 mL in 1 AMPULE (39822-5550-5)
source: ndc

Packages (1)

39822-5550-6 25 AMPULE in 1 CARTON (39822-5550-6) / 1 mL in 1 AMPULE (39822-5550-5)

Ingredients (1)

promethazine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

PROMETHAZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0e860109-725f-1c28-e063-6394a90a50ef", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992858"], "spl_set_id": ["b6f6698f-f23c-452a-9b38-bbb96ab88ae4"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 CARTON (39822-5550-6)  / 1 mL in 1 AMPULE (39822-5550-5)", "package_ndc": "39822-5550-6", "marketing_start_date": "20150130"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "39822-5550_0e860109-725f-1c28-e063-6394a90a50ef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "39822-5550", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA040737", "marketing_category": "ANDA", "marketing_start_date": "20150130", "listing_expiration_date": "20261231"}