Baclofen
- Product NDC
- 55154-4349
- 11-digit product format
- 551544349
- Labeler code
- 55154
- Product ID
- 55154-4349_cd2f219e-ae38-4182-ae26-7042881ee6b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2024-11-22
- Substance
- BACLOFEN
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-4349-0 | Baclofen | 10 in 1 BAG | TABLET | 10 | | 3 |
| 55154-4349-0 | Baclofen | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-4349 | BACLOFEN TABLET [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20241123_3c87e116-871d-46b8-897b-fc27a17b988d.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 |
|---|
| 55154-4349-0 | 55154434900 | 10 BLISTER PACK in 1 BAG (55154-4349-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-11-22 | No | No | Current |