KETALAR
- Product NDC
- 0404-9880
- 11-digit product format
- 004049880
- Labeler code
- 0404
- Product ID
- 0404-9880_66dc4477-9189-4ff8-b778-8ceb17a50802
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketamine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc
- Application
- NDA016812
- Marketing category
- NDA
- Marketing start
- 2022-01-11
- Substance
- KETAMINE HYDROCHLORIDE
- Active strength
- 10 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
- KETALAR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O18YUO0I83 |
| Rxcui | 206967, 238082 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9880-20 | KETALAR | 20 mL in 1 VIAL | INJECTION | 20 | | 5 |
| 0404-9880-20 | KETALAR | 1 in 1 BAG | INJECTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9880 | KETALAR (KETAMINE HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250129_46dab560-8ecd-4d92-8c92-6baa2310b09b.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 |
|---|
| 0404-9880-20 | 00404988020 | 1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIAL | 1 vial | 2022-01-11 | 0000-00-00 | No | No | Current |