BACLOFEN
- Product NDC
- 71225-140
- 11-digit product format
- 712250140
- Labeler code
- 71225
- Product ID
- 71225-140_f948e217-c9bb-4ec1-b5fb-864cc14afe4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Slayback Pharma LLC
- Application
- ANDA217252
- Marketing category
- ANDA
- Marketing start
- 2023-06-19
- Substance
- BACLOFEN
- Active strength
- 5 mg/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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 2593376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71225-140-01 | BACLOFEN | 1 in 1 CARTON | SUSPENSION | 1 | | 4 |
| 71225-140-01 | BACLOFEN | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71225-140 | BACLOFEN SUSPENSION [SLAYBACK PHARMA LLC] | 4 | Current NDC, 2 package rows | 20230622_9fad5ffc-afae-4c92-a672-ee636df45bc5.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 |
|---|
| 71225-140-01 | 71225014001 | 1 BOTTLE in 1 CARTON (71225-140-01) / 250 mL in 1 BOTTLE | 1 bottle | 2023-06-19 | No | No | Historical |