BACLOFEN
- Product NDC
- 82461-718
- 11-digit product format
- 824610718
- Labeler code
- 82461
- Product ID
- 82461-718_152e2f4d-157b-4dad-8d18-ab3f63792051
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medcore LLC
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2026-03-27
- 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
- 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 | 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 |
|---|
| 82461-718-10 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | | 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 |
|---|
| 82461-718-10 | 82461071810 | 100 TABLET in 1 BOTTLE (82461-718-10) | 100 tablet | 2026-03-27 | No | No | Historical |