Home NDC 65219-188 ketamine hydrochloride
Product NDC 65219-188
11-digit product format 652190188
Labeler code 65219
Product ID 65219-188_9acdebb0-6e88-42b2-ac45-da51aaad0f3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketamine hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA215808
Marketing category ANDA
Marketing start 2023-07-10
Substance KETAMINE HYDROCHLORIDE
Active strength 50 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215808-001 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 A215808-002 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 A215808-003 KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 56 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215808-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215808-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215808-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215808-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215808-003 KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE / INJECTION AP 2025-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2023-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215808-002 KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE / INJECTION 2023-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215808-001 KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE / INJECTION 2023-01-13 1c564ffb4f44…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ketamine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETAMINE HYDROCHLORIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O18YUO0I83 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238082 Internal RxNorm lookup 238083 Internal RxNorm lookup 238084 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-188-01 ketamine hydrochloride 10 mL in 1 VIAL INJECTION 10 2 65219-188-10 ketamine hydrochloride 10 in 1 TRAY INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-188 KETAMINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC
] 2 Current NDC, 2 package rows 20250427_cc67b0fd-ca73-49f6-b5ca-705dc7331776.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-188-01 65219018801 10 mL in 1 VIAL 10 ml Historical 65219-188-10 65219018810 10 VIAL in 1 TRAY (65219-188-10) / 10 mL in 1 VIAL (65219-188-01) 10 vial 2023-07-10 No No Current