BACLOFEN
- Product NDC
- 0615-8467
- 11-digit product format
- 006158467
- Labeler code
- 0615
- Product ID
- 0615-8467_9c2e25e4-823f-4ac2-82f4-674049807af5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- Substance
- BACLOFEN
- Active strength
- 20 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
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8467-39 | BACLOFEN | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8467 | BACLOFEN TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20230602_2927228a-7a3e-4e1d-ab5f-4407b00f6899.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 |
|---|
| 0615-8467-39 | 00615846739 | 30 TABLET in 1 BLISTER PACK (0615-8467-39) | 30 tablet | 2023-05-18 | No | No | Current |