ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: civica, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler civica, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 100 mg/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-321
Product ID 72572-321_675b63de-32c3-4205-9532-f018e3d3761a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074524
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-12-05

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572321
Hyphenated Format 72572-321

Supplemental Identifiers

RxCUI
238083 238084
UPC
0372572321105
UNII
O18YUO0I83

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 ketamine hydrochloride (source: ndc)
Generic Name ketamine hydrochloride (source: ndc)
Application Number ANDA074524 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (72572-321-10) / 5 mL in 1 VIAL (72572-321-01)
source: ndc

Packages (1)

72572-321-10 10 VIAL in 1 BOX (72572-321-10) / 5 mL in 1 VIAL (72572-321-01)

Ingredients (1)

ketamine hydrochloride (100 mg/mL)

Linked Drug Pages (1)

Ketamine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "675b63de-32c3-4205-9532-f018e3d3761a", "openfda": {"upc": ["0372572321105"], "unii": ["O18YUO0I83"], "rxcui": ["238083", "238084"], "spl_set_id": ["58c86d9b-8694-4bd8-8254-f19ee3ad60b0"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (72572-321-10)  / 5 mL in 1 VIAL (72572-321-01)", "package_ndc": "72572-321-10", "marketing_start_date": "20191205"}], "brand_name": "Ketamine Hydrochloride", "product_id": "72572-321_675b63de-32c3-4205-9532-f018e3d3761a", "dosage_form": "INJECTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "72572-321", "dea_schedule": "CIII", "generic_name": "Ketamine Hydrochloride", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketamine Hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA074524", "marketing_category": "ANDA", "marketing_start_date": "20191205", "listing_expiration_date": "20261231"}