chlorpromazine hydrochloride

Generic: chlorpromazine hydrochloride

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

Drug Facts

Product Profile

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

chlorpromazine hydrochloride 25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-1397
Product ID 0641-1397_5192ca14-ea80-4d18-9a66-2bcf7bfd094c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083329
Listing Expiration 2026-12-31
Marketing Start 1974-07-25

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06411397
Hyphenated Format 0641-1397

Supplemental Identifiers

RxCUI
1730076 1730078
UNII
9WP59609J6

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 chlorpromazine hydrochloride (source: ndc)
Generic Name chlorpromazine hydrochloride (source: ndc)
Application Number ANDA083329 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 25 AMPULE in 1 CARTON (0641-1397-35) / 1 mL in 1 AMPULE (0641-1397-31)
source: ndc

Packages (1)

0641-1397-35 25 AMPULE in 1 CARTON (0641-1397-35) / 1 mL in 1 AMPULE (0641-1397-31)

Ingredients (1)

chlorpromazine hydrochloride (25 mg/mL)

Linked Drug Pages (1)

Chlorpromazine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "5192ca14-ea80-4d18-9a66-2bcf7bfd094c", "openfda": {"unii": ["9WP59609J6"], "rxcui": ["1730076", "1730078"], "spl_set_id": ["c0f1fcfd-8863-4032-bf80-185df60a4ba0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 AMPULE in 1 CARTON (0641-1397-35)  / 1 mL in 1 AMPULE (0641-1397-31)", "package_ndc": "0641-1397-35", "marketing_start_date": "19740725"}], "brand_name": "Chlorpromazine hydrochloride", "product_id": "0641-1397_5192ca14-ea80-4d18-9a66-2bcf7bfd094c", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0641-1397", "generic_name": "Chlorpromazine hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorpromazine hydrochloride", "active_ingredients": [{"name": "CHLORPROMAZINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "ANDA083329", "marketing_category": "ANDA", "marketing_start_date": "19740725", "listing_expiration_date": "20261231"}