FDA.reportPublic FDA data

KETAMINE HYDROCHLORIDE

Product NDC
43066-117
11-digit product format
430660117
Labeler code
43066
Product ID
43066-117_415df0b7-eaea-467c-bad1-b1e3757487b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETAMINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA219684
Marketing category
ANDA
Marketing start
2025-09-17
Substance
KETAMINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219684-001KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17
A219684-002KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-1784e616aacf4f…
2026-09-14 22:38:342026-08A219684-002KETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17caaa826d4ba7…
2026-08-18 06:07:402026-07A219684-002KETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2026-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2025-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSRS2025-09-1731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219684-001KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS2025-09-17a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
KETAMINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETAMINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O18YUO0I83Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2723913Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
549d6ed3-3c9b-4ea2-8aaf-f61d43e04602Available on FDA.report

DailyMed Product Concepts#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETAMINE HYDROCHLORIDEKETAMINE HYDROCHLORIDEBaxter Healthcare Corporation549d6ed3-3c9b-4ea2-8aaf-f61d43e046022025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219684
application number: ANDA219684
ndc (product): 43066-117

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723913ketamine 100 MG in 10 ML Prefilled SyringePSN549d6ed3-3c9b-4ea2-8aaf-f61d43e046024
272391310 ML ketamine 10 MG/ML Prefilled SyringeSCD549d6ed3-3c9b-4ea2-8aaf-f61d43e046024
2723913ketamine 100 MG (as ketamine hydrochloride 115.3 MG) per 10 ML Prefilled SyringeSY549d6ed3-3c9b-4ea2-8aaf-f61d43e046024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-117-05430660117055 CARTON in 1 CARTON (43066-117-05) / 1 SYRINGE, PLASTIC in 1 CARTON (43066-117-01) / 10 mL in 1 SYRINGE, PLASTIC5 carton2025-09-17NoNoCurrent