chlorpromazine hydrochloride

Generic: chlorpromazine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorpromazine hydrochloride
Generic Name chlorpromazine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

chlorpromazine hydrochloride 25 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-534
Product ID 68083-534_ffd998aa-4c6f-4463-b77c-9dc2e722b948
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216911
Listing Expiration 2026-12-31
Marketing Start 2024-10-04

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083534
Hyphenated Format 68083-534

Supplemental Identifiers

RxCUI
1730076 1730078
UPC
0368083534257 0368083533250
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 ANDA216911 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-534-25) / 2 mL in 1 VIAL
source: ndc

Packages (1)

68083-534-25 25 VIAL in 1 CARTON (68083-534-25) / 2 mL in 1 VIAL

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": "ffd998aa-4c6f-4463-b77c-9dc2e722b948", "openfda": {"upc": ["0368083534257", "0368083533250"], "unii": ["9WP59609J6"], "rxcui": ["1730076", "1730078"], "spl_set_id": ["867d5c7f-52d4-4794-b1d4-6747f3262fba"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-534-25)  / 2 mL in 1 VIAL", "package_ndc": "68083-534-25", "marketing_start_date": "20241004"}], "brand_name": "Chlorpromazine hydrochloride", "product_id": "68083-534_ffd998aa-4c6f-4463-b77c-9dc2e722b948", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68083-534", "generic_name": "Chlorpromazine hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorpromazine hydrochloride", "active_ingredients": [{"name": "CHLORPROMAZINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "ANDA216911", "marketing_category": "ANDA", "marketing_start_date": "20241004", "listing_expiration_date": "20261231"}