KETAMINE HYDROCHLORIDE
- Product NDC
- 55150-440
- 11-digit product format
- 551500440
- Labeler code
- 55150
- Product ID
- 55150-440_35913e3d-e141-4596-bc4c-72deb8cbf932
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETAMINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA076092
- Marketing category
- ANDA
- Marketing start
- 2021-03-15
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETAMINE HYDROCHLORIDE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O18YUO0I83 |
| Rxcui | 238082, 238083, 238084 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-440-10 | KETAMINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION | 10 | | 6 |
| 55150-440-10 | KETAMINE HYDROCHLORIDE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-440 | KETAMINE HYDROCHLORIDE INJECTION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240207_f8b01c77-620d-4734-a771-b8524b65bcca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-440-10 | 55150044010 | 10 VIAL, MULTI-DOSE in 1 CARTON (55150-440-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2021-03-15 | 0000-00-00 | No | No | Current |