Baclofen
- Product NDC
- 25021-679
- 11-digit product format
- 250210679
- Labeler code
- 25021
- Product ID
- 25021-679_9ae563da-240a-468d-bc42-ed4667df2392
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA210048
- Marketing category
- ANDA
- Marketing start
- 2021-07-15
- Substance
- BACLOFEN
- Active strength
- 2000 ug/mL
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 2000 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 308517, 1666613 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-679-20 | Baclofen | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 25021-679-20 | Baclofen | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-679 | BACLOFEN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210715_077aaf3b-1ca3-4599-a51a-6bbe39810ca8.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 |
|---|
| 25021-679-20 | 25021067920 | 1 VIAL in 1 CARTON (25021-679-20) / 20 mL in 1 VIAL | 1 vial | 2021-07-15 | 0000-00-00 | No | No | Current |