FDA.reportPublic FDA data

Ketamine Hydrochloride

Product NDC
0409-2051
11-digit product format
004092051
Labeler code
0409
Product ID
0409-2051_37921fa5-8ef5-4af7-bf99-3a9ab24fa752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketamine Hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074549
Marketing category
ANDA
Marketing start
2004-11-30
Substance
KETAMINE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketamine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETAMINE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO18YUO0I83

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bcProduct name220240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2051-05Ketamine Hydrochloride10 in 1 BOXINJECTION, SOLUTION, CONCENTRATE1019
0409-2051-15Ketamine Hydrochloride5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2051-05ML - Milliliter0409-20515af8ee48-3d9c-4dcd-9356-2e7dddfd459712012-07-24
0409-2051-15ML - Milliliter0409-205130d3e57a-9930-4147-936f-a9cd40a2026f12020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETAMINE HYDROCHLORIDEACTIVE INGREDIENTO18YUO0I83KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
KETAMINEACTIVE MOIETY690G0D6V8HKETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2051KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]19Current NDC, Legacy NDC, 2 package rows20240717_bb912318-2e22-4469-b0a2-774803ee1bb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238083ketamine 100 MG/ML Injectable SolutionPSN6c56845e-2deb-4783-9dfd-a03c2ed7980c7
238083ketamine 100 MG/ML Injectable SolutionSCD6c56845e-2deb-4783-9dfd-a03c2ed7980c7
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSY6c56845e-2deb-4783-9dfd-a03c2ed7980c7
238083ketamine 100 MG/ML Injectable SolutionPSNea600f8a-857f-4e0e-e053-2995a90a017d3
238083ketamine 100 MG/ML Injectable SolutionSCDea600f8a-857f-4e0e-e053-2995a90a017d3
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSYea600f8a-857f-4e0e-e053-2995a90a017d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2051-050040920510510 VIAL, MULTI-DOSE in 1 BOX (0409-2051-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-2051-15) 2004-11-300000-00-00NoNoCurrent
0409-2051-15004092051155 mL in 1 VIAL, MULTI-DOSE5 mlHistorical