KETAMINE HYDROCHLORIDE
- Product NDC
- 0404-9882
- 11-digit product format
- 004049882
- Labeler code
- 0404
- Product ID
- 0404-9882_fb0436cf-9ef7-4b0b-8c47-8068ffc0bbf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketamine hydrochloride
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA074549
- Marketing category
- ANDA
- Marketing start
- 2022-01-11
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O18YUO0I83 |
| Rxcui | 238084 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9882-10 | KETAMINE HYDROCHLORIDE | 10 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 10 | | 5 |
| 0404-9882-10 | KETAMINE HYDROCHLORIDE | 1 in 1 BAG | INJECTION, SOLUTION, CONCENTRATE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9882 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241016_dd8eff00-b92e-4f48-8b57-0464484d6ddf.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 |
|---|
| 0404-9882-10 | 00404988210 | 1 VIAL in 1 BAG (0404-9882-10) / 10 mL in 1 VIAL | 1 vial | 2022-01-11 | 0000-00-00 | No | No | Current |