BACLOFEN
- Product NDC
- 72888-147
- 11-digit product format
- 728880147
- Labeler code
- 72888
- Product ID
- 72888-147_45801dc3-fb9b-c31e-e063-6294a90aff35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Advagen Pharma Limited
- 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 | 308517, 1300890, 1666613 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-147-36 | BACLOFEN | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 6 |
| 72888-147-36 | BACLOFEN | 1 in 1 CARTON | INJECTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-147 | BACLOFEN INJECTION [ADVAGEN PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20230307_d63af5f0-c275-480b-89b5-6cf1ad55ab63.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-147-36 | 72888014736 | 1 VIAL, GLASS in 1 CARTON (72888-147-36) / 20 mL in 1 VIAL, GLASS | 2023-02-22 | No | No | Current |