BACLOFEN
- Product NDC
- 14789-161
- 11-digit product format
- 147890161
- Labeler code
- 14789
- Product ID
- 14789-161_2ac0f53e-48b5-5d84-e063-6294a90a8ac8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Nexus Pharmaceuticals LLC
- Application
- ANDA217324
- Marketing category
- ANDA
- Marketing start
- 2023-02-22
- 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 | 1666613 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14789-161-05 | BACLOFEN | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 14789-161-05 | BACLOFEN | 20 mL in 1 VIAL | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14789-161 | BACLOFEN INJECTION [NEXUS PHARMACEUTICALS LLC] | 2 | Current NDC, 2 package rows | 20250110_68c9ade0-d783-43e9-8a3f-a16ec1501ec1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14789-161-05 | 14789016105 | 1 VIAL in 1 CARTON (14789-161-05) / 20 mL in 1 VIAL | 1 vial | 2023-02-22 | No | No | Current |