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 INTRAVENOUS
Active Ingredients

promethazine hydrochloride 25 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9940
Product ID 0404-9940_b335e8fd-c887-497f-8bd4-117820a406f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083312
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049940
Hyphenated Format 0404-9940

Supplemental Identifiers

RxCUI
992460
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 INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9940-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

promethazine hydrochloride (25 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": "b335e8fd-c887-497f-8bd4-117820a406f7", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992460"], "spl_set_id": ["7fa840ad-10e7-4faf-9325-451648604161"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9940-01", "marketing_start_date": "20220113"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "0404-9940_b335e8fd-c887-497f-8bd4-117820a406f7", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0404-9940", "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": "25 mg/mL"}], "application_number": "ANDA083312", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}