promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

promethazine hydrochloride 25 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-928
Product ID 84549-928_463d23fc-cb4b-0346-e063-6394a90a2df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083312
Listing Expiration 2026-12-31
Marketing Start 1973-09-19

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549928
Hyphenated Format 84549-928

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 mL in 1 VIAL, SINGLE-DOSE (84549-928-25)
source: ndc

Packages (1)

84549-928-25 1 mL in 1 VIAL, SINGLE-DOSE (84549-928-25)

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": "463d23fc-cb4b-0346-e063-6394a90a2df2", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992460"], "spl_set_id": ["38673af1-112e-9ddd-e063-6294a90af465"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (84549-928-25)", "package_ndc": "84549-928-25", "marketing_start_date": "20250827"}], "brand_name": "Promethazine Hydrochloride", "product_id": "84549-928_463d23fc-cb4b-0346-e063-6394a90a2df2", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "84549-928", "generic_name": "Promethazine Hydrochloride", "labeler_name": "ProPharma Distribution", "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": "20261231"}