DEXMEDETOMIDINE
- Product NDC
- 16729-432
- 11-digit product format
- 167290432
- Labeler code
- 16729
- Product ID
- 16729-432_ad2504de-4b7e-16ff-e053-2a95a90a60b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA204023
- Marketing category
- ANDA
- Marketing start
- 2018-08-31
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-432 | DEXMEDETOMIDINE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] | 3 | Legacy NDC | 20200819_aa450b4b-4969-465d-b7f2-8da380bbdbed.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-432-93 | 16729043293 | 25 VIAL in 1 CARTON (16729-432-93) > 2 mL in 1 VIAL (16729-432-30) | 25 vial | 2018-08-31 | 0000-00-00 | No | No | Current |