BACLOFEN
- Product NDC
- 55154-0198
- 11-digit product format
- 551540198
- Labeler code
- 55154
- Product ID
- 55154-0198_ae6c8772-e83b-4d39-884c-2fb324baea37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2026-03-23
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-0198-0 | BACLOFEN | 1 in 1 BAG | TABLET | 1 | | 2 |
| 55154-0198-0 | BACLOFEN | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-0198-0 | 55154019800 | 1 BLISTER PACK in 1 BAG (55154-0198-0) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2026-03-23 | No | No | Current |