promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

promethazine hydrochloride 25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0948
Product ID 0641-0948_9b956a99-5a3c-4932-9d4e-804bbea8cee4
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 06410948
Hyphenated Format 0641-0948

Supplemental Identifiers

RxCUI
992460 992858
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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
  • 25 AMPULE in 1 CARTON (0641-0948-35) / 1 mL in 1 AMPULE (0641-0948-31)
source: ndc

Packages (1)

0641-0948-35 25 AMPULE in 1 CARTON (0641-0948-35) / 1 mL in 1 AMPULE (0641-0948-31)

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": "9b956a99-5a3c-4932-9d4e-804bbea8cee4", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992460", "992858"], "spl_set_id": ["d545105f-27dc-4820-b0b1-fcf17e0be0f0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 CARTON (0641-0948-35)  / 1 mL in 1 AMPULE (0641-0948-31)", "package_ndc": "0641-0948-35", "marketing_start_date": "19730919"}], "brand_name": "Promethazine Hydrochloride", "product_id": "0641-0948_9b956a99-5a3c-4932-9d4e-804bbea8cee4", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0641-0948", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA 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": "19730919", "listing_expiration_date": "20261231"}