ketamine hydrochloride
- Product NDC
- 65219-186
- 11-digit product format
- 652190186
- Labeler code
- 65219
- Product ID
- 65219-186_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
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O18YUO0I83 |
| Rxcui | 238082, 238083, 238084 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-186-01 | ketamine hydrochloride | 5 mL in 1 VIAL | INJECTION | 5 | | 2 |
| 65219-186-05 | ketamine hydrochloride | 10 in 1 TRAY | INJECTION | 10 | | 2 |
| 65219-186-13 | ketamine hydrochloride | 5 mL in 1 VIAL | INJECTION | 5 | | 1 |
| 65219-186-23 | ketamine hydrochloride | 10 in 1 TRAY | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-186 | KETAMINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC
] | 2 | Current NDC, 2 package rows | 20250427_cc67b0fd-ca73-49f6-b5ca-705dc7331776.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-186-01 | 65219018601 | 5 mL in 1 VIAL | 5 ml | | | | Historical |
| 65219-186-05 | 65219018605 | 10 VIAL in 1 TRAY (65219-186-05) / 5 mL in 1 VIAL (65219-186-01) | 10 vial | 2025-04-18 | No | No | Historical |
| 65219-186-13 | 65219018613 | 5 mL in 1 VIAL | 5 ml | | | | Historical |
| 65219-186-23 | 65219018623 | 10 VIAL in 1 TRAY (65219-186-23) / 5 mL in 1 VIAL (65219-186-13) | 10 vial | 2025-04-18 | No | No | Historical |