Baclofen
- Product NDC
- 67457-564
- 11-digit product format
- 674570564
- Labeler code
- 67457
- Product ID
- 67457-564_024758c9-c94b-4ebe-8e7e-a47c39488e74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Mylan Institutional LLC
- Application
- ANDA209592
- Marketing category
- ANDA
- Marketing start
- 2018-12-21
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 40 mg/20mL
- Pharmacologic classes
- GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-564 | BACLOFEN INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 5 | Legacy NDC | 20241215_469be477-1379-416a-a492-3ebbcc4a6a84.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-564-20 | 67457056420 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-564-20) > 20 mL in 1 VIAL, SINGLE-DOSE | 2018-12-21 | 0000-00-00 | No | No | Current |