Baclofen
- Product NDC
- 70511-123
- 11-digit product format
- 705110123
- Labeler code
- 70511
- Product ID
- 70511-123_c25028b0-ac87-4b40-b8e4-fef625b32ccb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- MAlA Pharmaceuticals, Inc.
- Application
- ANDA210315
- Marketing category
- ANDA
- Marketing start
- 2020-12-23
- Substance
- BACLOFEN
- Active strength
- 1000 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 | 1000 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 1300890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70511-123-20 | Baclofen | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 70511-123-20 | Baclofen | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70511-123 | BACLOFEN INJECTION [MALA PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230116_dfa6148c-693c-45f1-89be-0e77d39f313e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70511-123-20 | 70511012320 | 1 VIAL, GLASS in 1 CARTON (70511-123-20) / 20 mL in 1 VIAL, GLASS | 2020-12-23 | 0000-00-00 | No | No | Current |