KETAMINE HYDROCHLORIDE
- Product NDC
- 0404-9881
- 11-digit product format
- 004049881
- Labeler code
- 0404
- Product ID
- 0404-9881_0d7587dc-b5db-4979-8bda-d3597a1ff482
- 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
- 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 | 238083 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9881-05 | KETAMINE HYDROCHLORIDE | 1 in 1 BAG | INJECTION, SOLUTION, CONCENTRATE | 1 | | 7 |
| 0404-9881-05 | KETAMINE HYDROCHLORIDE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9881 | KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240504_6c56845e-2deb-4783-9dfd-a03c2ed7980c.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 |
|---|
| 0404-9881-05 | 00404988105 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9881-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2022-01-11 | 0000-00-00 | No | No | Current |