Baclofen
- Product NDC
- 45865-355
- 11-digit product format
- 458650355
- Labeler code
- 45865
- Product ID
- 45865-355_9adb5c2f-69b8-4c26-e053-2995a90aa4af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 20 mg/1
- 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-355-51 | Baclofen | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-355 | BACLOFEN TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 1 package rows | 20191230_9adb5c2f-69b7-4c26-e053-2995a90aa4af.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 |
|---|
| 45865-355-51 | 45865035551 | 120 TABLET in 1 BOTTLE, PLASTIC (45865-355-51) | 120 tablet | 2018-12-12 | 0000-00-00 | No | No | Current |