Ketalar

Product NDC
42023-115
11-digit product format
420230115
Labeler code
42023
Product ID
42023-115_00836cdd-f898-4031-85f8-bb58a63b1a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketamine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA016812
Marketing category
NDA
Marketing start
2007-10-01
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016812-001KETALARKETAMINE HYDROCHLORIDEEQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016812-002KETALARKETAMINE HYDROCHLORIDEEQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982
N016812-003KETALARKETAMINE HYDROCHLORIDEEQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N016812-001AP
N016812-002AP
N016812-003AP

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-002KETALAREQ 50MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-003KETALAREQ 100MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016812-001KETALAREQ 10MG BASE/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N016812-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N016812-002AP184e616aacf4f…
2026-09-14 22:38:342026-08N016812-003AP184e616aacf4f…
2026-08-18 06:07:402026-07N016812-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016812-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016812-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016812-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016812-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016812-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016812-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016812-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016812-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016812-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016812-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016812-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016812-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016812-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016812-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016812-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016812-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016812-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016812-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016812-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016812-001AP1301d65b070ca…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETAMINE HYDROCHLORIDE100 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206967Internal RxNorm lookup
206970Internal RxNorm lookup
206972Internal RxNorm lookup
238082Internal RxNorm lookup
238083Internal RxNorm lookup
238084Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14e8f864-8b8a-4e7e-8439-e510d3107063Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb4bf50b-0475-bcb2-86ff-7b0cc2cc55bcProduct name220240223
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-115-10Ketalar5 mL in 1 VIALINJECTION533
42023-115-10Ketalar10 in 1 CARTONINJECTION1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-115-10ML - Milliliter42023-1153708751e-af4b-41b6-998d-1ea35dc3ef0812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketamine hydrochlorideACTIVE INGREDIENTO18YUO0I83KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
ketamineACTIVE MOIETY690G0D6V8HKETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
benzethonium chlorideINACTIVE INGREDIENTPH41D05744KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6
sodium chlorideINACTIVE INGREDIENT451W47IQ8XKETALAR (KETAMINE HYDROCHLORIDE) INJECTION [PAR PHARMACEUTICAL, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-115KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [ENDO USA, INC.]23Current NDC, Legacy NDC, 2 package rows20240913_14e8f864-8b8a-4e7e-8439-e510d3107063.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetalarKETAMINE HYDROCHLORIDEPar Health USA, LLC14e8f864-8b8a-4e7e-8439-e510d31070632026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 016812
application number: NDA016812
ndc (product): 42023-115
KETALARKETAMINE HYDROCHLORIDEHenry Schein, Inc46dab560-8ecd-4d92-8c92-6baa2310b09b2025-01-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 016812
application number: NDA016812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206967Ketalar 10 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206970Ketalar 100 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206972Ketalar 50 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine 10 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine 100 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine 50 MG/ML Injectable SolutionPSN14e8f864-8b8a-4e7e-8439-e510d310706333
206967ketamine 10 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
206970ketamine 100 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
206972ketamine 50 MG/ML Injectable Solution [Ketalar]SBD14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine 10 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine 100 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine 50 MG/ML Injectable SolutionSCD14e8f864-8b8a-4e7e-8439-e510d310706333
206967Ketalar (ketamine hydrochloride) 10 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
206970Ketalar (ketamine hydrochloride) 100 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
206972Ketalar (ketamine hydrochloride) 50 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238082ketamine (as ketamine hydrochloride) 10 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238083ketamine (as ketamine hydrochloride) 100 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333
238084ketamine (as ketamine hydrochloride) 50 MG/ML Injectable SolutionSY14e8f864-8b8a-4e7e-8439-e510d310706333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-115-104202301151010 VIAL in 1 CARTON (42023-115-10) / 5 mL in 1 VIAL10 vial2007-10-010000-00-00NoNoCurrent