Dexmedetomidine Hydrochloride
- Product NDC
- 63323-421
- 11-digit product format
- 633230421
- Labeler code
- 63323
- Product ID
- 63323-421_56e0af34-aeb5-4b37-8c61-2e90b2c8ca6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmedetomidine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA201072
- Marketing category
- ANDA
- Marketing start
- 2015-09-18
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmedetomidine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 309710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-421-01 | Dexmedetomidine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 9 |
| 63323-421-02 | Dexmedetomidine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | 1018WH7F9I | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| DEXMEDETOMIDINE | ACTIVE MOIETY | 67VB76HONO | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-421 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221123_c1b8eb58-596b-481d-beb6-ba9d2237abf4.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 |
|---|
| 63323-421-01 | 63323042101 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 63323-421-02 | 63323042102 | 25 VIAL in 1 TRAY (63323-421-02) / 2 mL in 1 VIAL (63323-421-01) | 25 vial | 2015-09-18 | 0000-00-00 | No | No | Current |