Ketamine Hydrochloride
- Product NDC
- 0143-9508
- 11-digit product format
- 001439508
- Labeler code
- 0143
- Product ID
- 0143-9508_6ada9356-0968-46df-b067-d95509650c48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketamine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA074524
- Marketing category
- ANDA
- Marketing start
- 1996-07-01
- 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 | 238083, 238084 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9508-01 | Ketamine Hydrochloride | 10 mL in 1 VIAL | INJECTION | 10 | | 8 |
| 0143-9508-10 | Ketamine Hydrochloride | 10 in 1 BOX | INJECTION | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9508 | KETAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240228_58487c78-a641-4278-acc0-343596ee8683.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 |
|---|
| 0143-9508-01 | 00143950801 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0143-9508-10 | 00143950810 | 10 VIAL in 1 BOX (0143-9508-10) / 10 mL in 1 VIAL (0143-9508-01) | 10 vial | 1996-07-01 | 0000-00-00 | No | No | Current |