promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler cardinal health 107, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

promethazine hydrochloride 25 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-2861
Product ID 55154-2861_5002c2f5-9a52-44a9-a6a1-5e4bd811b7c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083312
Listing Expiration 2027-12-31
Marketing Start 1973-09-19

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551542861
Hyphenated Format 55154-2861

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
  • 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2861-5) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55154-2861-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2861-5) / 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": "5002c2f5-9a52-44a9-a6a1-5e4bd811b7c4", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992460"], "spl_set_id": ["7ce351d8-47be-4937-aad2-153208c93b53"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BAG (55154-2861-5)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55154-2861-5", "marketing_start_date": "19730919"}], "brand_name": "Promethazine Hydrochloride", "product_id": "55154-2861_5002c2f5-9a52-44a9-a6a1-5e4bd811b7c4", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "55154-2861", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "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": "19730919", "listing_expiration_date": "20271231"}