PRECEDEX
- Product NDC
- 0404-9938
- 11-digit product format
- 004049938
- Labeler code
- 0404
- Product ID
- 0404-9938_e1501aca-8b05-43eb-be48-9ec222ff4428
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- NDA021038
- Marketing category
- NDA
- Marketing start
- 2022-01-13
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRECEDEX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 284397, 309710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9938-02 | PRECEDEX | 2 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 2 | | 9 |
| 0404-9938-02 | PRECEDEX | 1 in 1 BAG | INJECTION, SOLUTION, CONCENTRATE | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9938 | PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241024_9eb336de-5fa5-4b46-b40b-a7ca5a0864bd.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 |
|---|
| 0404-9938-02 | 00404993802 | 1 VIAL in 1 BAG (0404-9938-02) / 2 mL in 1 VIAL | 1 vial | 2022-01-13 | 0000-00-00 | No | No | Current |