Baclofen (intrathecal)
- Product NDC
- 71525-010
- 11-digit product format
- 715250010
- Labeler code
- 71525
- Product ID
- 71525-010_66d85337-b4ad-403e-8631-3123311477b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Emerald International Limited
- Application
- ANDA091193
- Marketing category
- ANDA
- Marketing start
- 2018-12-01
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 10 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71525-010-01 | Baclofen (intrathecal) | 1 in 1 BOX | INJECTION | 1 | | 2 |
| 71525-010-20 | Baclofen (intrathecal) | 20 mL in 1 AMPULE | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71525-010 | BACLOFEN (INTRATHECAL) (BACLOFEN) INJECTION [EMERALD INTERNATIONAL LIMITED] | 2 | Legacy NDC, 2 package rows | 20181201_63c13374-f4d1-4437-a703-acb8211f2ae4.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 |
|---|
| 71525-010-01 | 71525001001 | 1 AMPULE in 1 BOX (71525-010-01) > 20 mL in 1 AMPULE (71525-010-20) | 1 ampule | 2018-12-01 | 0000-00-00 | No | No | Current |
| 71525-010-20 | 71525001020 | 20 mL in 1 AMPULE | 20 ml | | | | | Historical |