Baclofen
- Product NDC
- 72888-466
- 11-digit product format
- 728880466
- Labeler code
- 72888
- Product ID
- 72888-466_374c7fbe-ca7e-09b4-e063-6394a90ab5fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd.,
- Application
- ANDA214445
- Marketing category
- ANDA
- Marketing start
- 2025-06-03
- Substance
- BACLOFEN
- Active strength
- 10 mg/5mL
- 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 | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 2667941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-466-01 | Baclofen | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
| 72888-466-02 | Baclofen | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-466-01 | 72888046601 | 473 mL in 1 BOTTLE (72888-466-01) | 473 ml | 2025-06-03 | No | No | Current |
| 72888-466-02 | 72888046602 | 237 mL in 1 BOTTLE (72888-466-02) | 237 ml | 2025-06-03 | No | No | Current |