Baclofen
- Product NDC
- 17856-0620
- 11-digit product format
- 178560620
- Labeler code
- 17856
- Product ID
- 17856-0620_50ffb7ff-ed78-1b75-e063-6294a90a00fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp.
- Application
- NDA208193
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-10-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2027-12-31
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 |
|---|
| 17856-0620-1 | Baclofen | 2.5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 2.5 | | 2 |
| 17856-0620-1 | Baclofen | 72 in 1 CASE | SOLUTION | 72 | | 2 |
| 17856-0620-2 | Baclofen | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 2 |
| 17856-0620-2 | Baclofen | 72 in 1 CASE | SOLUTION | 72 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-0620-1 | 17856062001 | 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSE | 2026-04-30 | No | No | Current |
| 17856-0620-2 | 17856062002 | 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-2) / 5 mL in 1 CUP, UNIT-DOSE | 2026-04-30 | No | No | Current |