promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler a-s medication solutions
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

promethazine hydrochloride 50 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0879
Product ID 50090-0879_5cb280fa-c45d-4dbb-8e1d-c2271db20a77
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 500900879
Hyphenated Format 50090-0879

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
  • 25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

50090-0879-0 25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "5cb280fa-c45d-4dbb-8e1d-c2271db20a77", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992858"], "spl_set_id": ["c930985b-bba3-4f3a-a1ae-1d808670efde"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 PACKAGE (50090-0879-0)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "50090-0879-0", "marketing_start_date": "20141128"}], "brand_name": "Promethazine Hydrochloride", "product_id": "50090-0879_5cb280fa-c45d-4dbb-8e1d-c2271db20a77", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "50090-0879", "generic_name": "Promethazine Hydrochloride", "labeler_name": "A-S Medication Solutions", "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": "19730919", "listing_expiration_date": "20261231"}