Ketamine Hydrochloride
- Product NDC
- 0409-0040
- 11-digit product format
- 004090040
- Labeler code
- 0409
- Product ID
- 0409-0040_aa1e5788-73a9-4b95-99da-17eb252f8702
- 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
- 2022-10-10
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 100 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 |
|---|
| 0409-0040-05 | Ketamine Hydrochloride | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 4 |
| 0409-0040-10 | Ketamine Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-0040 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240521_390f2db8-0fcd-4648-b584-9effa084be27.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-0040-05 | 00409004005 | 10 VIAL, MULTI-DOSE in 1 BOX (0409-0040-05) > 5 mL in 1 VIAL, MULTI-DOSE (0409-0040-10) | 2022-10-10 | 0000-00-00 | No | No | Current |
| 0409-0040-10 | 00409004010 | 10 VIAL, MULTI-DOSE in 1 CARTON (0409-0040-10) / 5 mL in 1 VIAL, MULTI-DOSE (0409-0040-05) | 2022-10-10 | 0000-00-00 | No | No | Current |