Baclofen
- Product NDC
- 70511-121
- 11-digit product format
- 705110121
- Labeler code
- 70511
- Product ID
- 70511-121_58150ebf-c2d6-49be-a519-06d839637462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- MAlA Pharmaceuticals, Inc.
- Application
- ANDA210777
- Marketing category
- ANDA
- Marketing start
- 2021-04-02
- Substance
- BACLOFEN
- Active strength
- 50 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 | 50 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 1047437 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70511-121 | BACLOFEN INJECTION [MALA PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC | 20230525_e05080ef-53d9-4060-aaa4-86a6935467de.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 |
|---|
| 70511-121-80 | 70511012180 | 2 SYRINGE, GLASS in 1 CARTON (70511-121-80) / 1 mL in 1 SYRINGE, GLASS | | 2022-06-01 | | No | No | Current |
| 70511-121-83 | 70511012183 | 5 CARTON in 1 CARTON (70511-121-83) > 1 SYRINGE, GLASS in 1 CARTON (70511-121-06) > 1 mL in 1 SYRINGE, GLASS | 5 carton | 2021-04-02 | 0000-00-00 | No | No | Current |