promethazine hci

Generic: promethazine hci

Labeler: hf acquisition co. llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hci
Generic Name promethazine hci
Labeler hf acquisition co. llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

promethazine hydrochloride 50 mg/mL

Manufacturer
HF Acquisition Co. LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1248
Product ID 51662-1248_12004047-315d-77ac-e063-6294a90a77a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083312
Listing Expiration 2026-12-31
Marketing Start 2018-08-26

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621248
Hyphenated Format 51662-1248

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 hci (source: ndc)
Generic Name promethazine hci (source: ndc)
Application Number ANDA083312 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 mL in 1 AMPULE (51662-1248-1)
  • 25 POUCH in 1 CASE (51662-1248-3) / 1 AMPULE in 1 POUCH (51662-1248-2) / 1 mL in 1 AMPULE
source: ndc

Packages (2)

51662-1248-1 1 mL in 1 AMPULE (51662-1248-1) 51662-1248-3 25 POUCH in 1 CASE (51662-1248-3) / 1 AMPULE in 1 POUCH (51662-1248-2) / 1 mL in 1 AMPULE

Ingredients (1)

promethazine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

PROMETHAZINE HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "12004047-315d-77ac-e063-6294a90a77a3", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992858"], "spl_set_id": ["744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a"], "manufacturer_name": ["HF Acquisition Co. LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 AMPULE (51662-1248-1)", "package_ndc": "51662-1248-1", "marketing_start_date": "20180826"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1248-3)  / 1 AMPULE in 1 POUCH (51662-1248-2)  / 1 mL in 1 AMPULE", "package_ndc": "51662-1248-3", "marketing_start_date": "20180826"}], "brand_name": "PROMETHAZINE HCI", "product_id": "51662-1248_12004047-315d-77ac-e063-6294a90a77a3", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "51662-1248", "generic_name": "PROMETHAZINE HCI", "labeler_name": "HF Acquisition Co. LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HCI", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA083312", "marketing_category": "ANDA", "marketing_start_date": "20180826", "listing_expiration_date": "20261231"}