Ketamine Hydrochloride
- Product NDC
- 0409-2053
- 11-digit product format
- 004092053
- Labeler code
- 0409
- Product ID
- 0409-2053_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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketamine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O18YUO0I83 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-2053-10 | Ketamine Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION, CONCENTRATE | 10 | | 19 |
| 0409-2053-20 | Ketamine Hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| KETAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | O18YUO0I83 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 3 | |
| KETAMINE | ACTIVE MOIETY | 690G0D6V8H | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 3 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 3 | |
| KETAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | O18YUO0I83 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| KETAMINE | ACTIVE MOIETY | 690G0D6V8H | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2053 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240717_bb912318-2e22-4469-b0a2-774803ee1bb8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-2053-10 | 00409205310 | 10 VIAL, MULTI-DOSE in 1 BOX (0409-2053-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20) | | 2004-11-30 | 0000-00-00 | No | No | Current |
| 0409-2053-20 | 00409205320 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |