promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

promethazine hydrochloride 50 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9942
Product ID 0404-9942_b4183b6c-f338-4914-a618-75cb78c0bb7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083312
Listing Expiration 2026-12-31
Marketing Start 2022-01-17

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049942
Hyphenated Format 0404-9942

Supplemental Identifiers

RxCUI
992858
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 ANDA083312 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 AMPULE in 1 BAG (0404-9942-01) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

0404-9942-01 1 AMPULE in 1 BAG (0404-9942-01) / 1 mL in 1 AMPULE

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"], "spl_id": "b4183b6c-f338-4914-a618-75cb78c0bb7e", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992858"], "spl_set_id": ["c525cb2c-9a01-4a9b-ad2c-08630719953d"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 BAG (0404-9942-01)  / 1 mL in 1 AMPULE", "package_ndc": "0404-9942-01", "marketing_start_date": "20220117"}], "brand_name": "Promethazine Hydrochloride", "product_id": "0404-9942_b4183b6c-f338-4914-a618-75cb78c0bb7e", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0404-9942", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA083312", "marketing_category": "ANDA", "marketing_start_date": "20220117", "listing_expiration_date": "20261231"}